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VP WATCHLIST HIGHLIGHTS

You can review our complete VP Watchlist that we believe deserve consideration for short term and long term portfolio adds that include Apple, Tesla, & seven other names. The pages will enable you to stay informed and learn more about these companies daily.

Please review few of the updates on a few of the VP Watchlist companies below: 

• INmune Bio, Inc. (NASDAQ: INMB) closed at $10.06, -1.57%. INMB is a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease. INMB is further focused on modulating components of the innate immune system to activate an immune response against cancer and Alzheimer’s disease.
  

• • INmune Bio’s DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trial to determine if it can treat for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and treatment resistant depression (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation.

• • INMB reported its financial results for the first quarter ended March 31, 2021 and provided a business update on Wednesday, May 5th. RJ Tesi, M.D., chief executive officer of INmune Bio stated, “We continued to treat patients in the Phase I XPro1595 Alzheimer’s disease trial and expand the extensive biomarker data. The interim data that we reported in January confirms that XPro1595 decreases neuroinflammation in patients with Alzheimer’s disease and supports transitioning to a blinded randomized placebo-controlled Phase II trial later this year. We regard these results as extremely promising and look forward to further confirmation of XPro1595’s potential benefit to these patients in a rigorously designed Phase 2 study. We will report the additional biomarker data later this Summer. We have started screening patients in the Phase I INKmune NK cell priming platform trial in patients with high-risk myelodysplastic syndrome (MDS). MDS is a serious hematopoietic stem cell disorder in which patients have functionally defective NK cells, and approximately one-third of cases progress to AML. We created a short 5-minute video that we believe does a wonderful job explaining why NK cells fail to clear cancer and how the cellular and molecular interactions by INKmune activate NK cells to kill resistant tumors. The video can be found by clicking here.”

• • I am excited to be hosting Tribe Public’s Next Webinar Presentation and Q&A Event titled “Advancing Treatment To Repair Our Aging Innate Immune System to Fight Alzheimer’s” which will be held Tuesday, May 18 (1:15 pm PT/ 4:15 pm ET). Our events are approximately 30 minutes in duration. INMB’s CEO Dr. Raymond J. Tesi, MD and CFO David J. Moss of INmune Bio (NASDAQ: INMB) will deliver their presentation & will be also be available for a 5-10 minute Q&A session at the end of the presentation. Register for this FREE event at INMB.TribePublic.com.

• Natural-Killer cell (NKcell) focused biopharmaceutical firm Fate Therapeutics (FATE) closed at $72.29/share, -7.32%.

  • On May 5th, Fate reported business highlights and financial results for the first quarter ended March 31, 2021. Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics stated, “During the first quarter of 2021, we strengthened our balance sheet by raising $460 million and successfully positioned our off-the-shelf, iPSC-derived NK cell pipeline to achieve significant clinical milestones across our disease franchises throughout the remainder of the year. We look forward to sharing Phase 1 clinical data from our FT516 and FT538 programs in relapsed / refractory AML at an investor event to be held alongside the ASGCT conference. We are also pleased with the clinical expansion of our FT538 program into solid tumors, where we plan to combine with FDA-approved monoclonal antibodies targeting EGFR, HER2, and PDL1. While we are disappointed that the PROTECT study of ProTmune did not meet its primary endpoint for prevention of acute graft-versus-host disease following allogeneic stem cell transplant, we will now turn our full attention and resources to our deep pipeline of off-the-shelf, iPSC-derived cancer immunotherapies. We would like to sincerely thank the patients, caregivers and investigators who participated in the clinical investigation of ProTmune, and we intend to share our clinical findings with that community.”

  • On April, 27th the company announced that two oral and two digital presentations of the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 24th American Society of Gene & Cell Therapy Annual Meeting (ASGCT) being held virtually from May 11-14, 2021. In addition to the Company’s presentations at ASGCT, its iPSC-derived natural killer (NK) cell product pipeline is expected to be featured in a meeting symposium on May 11 by Jeffrey S. Miller, M.D., Professor of Medicine, University of Minnesota and Deputy Director of the Masonic Cancer Center and scientific advisor and collaborator of the Company, and its iPSC-derived CAR T-cell product platform is expected to be highlighted during the meeting’s plenary session on May 12 by Michel Sadelain, M.D., Ph.D., Stephen and Barbara Friedman Chair and Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center and collaborator of the Company. The Company also plans to host a virtual investor event on May 13 to highlight interim Phase 1 clinical data from its FT516 and FT538 programs for the treatment of relapsed / refractory acute myeloid leukemia (AML). The Phase 1 clinical trial of FT516 has enrolled the first and second dose cohorts (90 million and 300 million cells per dose, respectively), and dose escalation is ongoing in the third dose cohort (900 million cells per dose). The Phase 1 clinical trial of FT538 is ongoing in the first dose cohort (100 million cells per dose).

• • On March 25, FATE announced that Daniel D. Shoemaker, Ph.D., Chief Scientific Officer, has advised the Company that he is retiring as of June 30, 2021 after more than 12 years with the Company. Dr. Shoemaker has been with Fate Therapeutics since February 2009, having served as the Company’s Chief Scientific Officer since May 2015. Bob Valamehr, Ph.D., Chief Research and Development Officer of Fate Therapeutics and scientific leader of its iPSC Product Platform since January 2010, will continue to lead all research and development activities.

• • On Jan. 8, FATE announced the pricing of an underwritten public offering of ~$432 million at $85.50/share. Jefferies, BofA Securities, SVB Leerink and Barclays acted as joint book-running managers for the offering.

• • On Dec. 6, 2020, Fate presented a patient case study from the Company’s Phase 1 clinical trial of FT596, its universal, off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate, at the 62nd Annual Society of Hematology Annual Meeting and Exposition and the street loved it. NK cells are the body’s first line of defense against viral infections and cancerous cells with an innate ability to rapidly seek and destroy transformed cells. NK cell therapy has the potential to 1) target multiple pathogenic antigens with measurably more efficient cytotoxicity, 2) be better controlled to reduce risk of cytokine storms and 3) be produced from a variety of sources without relying on patient-specific immune cells. Dr. Wayne Chu, Senior Vice President, Clinical Development of Fate Therapeutics stated, “The safety, pharmacokinetics and clinical activity observed following both the first and second single-dose treatment cycles of FT596 are compelling, especially when considering that the administered cell dose was significantly lower than the recommended cell dose of FDA-approved autologous CD19-targeted CAR T-cell therapies and that the heavily pre-treated patient was refractory to last prior therapy. We are excited the CAR component of FT596 has shown clinical activity at this low dose level, and we continue to enroll patients in dose escalation with FT596 as a monotherapy and in combination with rituximab.”

• INVO Bioscience (NASDAQ: INVO) is a medical device company focused on creating alternative treatments for patients diagnosed with infertility and developers of INVOcell®, the world’s only in vivo Intravaginal Culture System. Shares of INVO closed at $3.94/share, +6.2% today. 

• Could we be setting up for another March 9, 2021 type of run where +96M shares traded for this low-float stock (~10M shares issued)and the stock shot to a new 52-week high of $12.30….?

• • On May 11, after the close, I found a 13G filed today that confirms that David Sable’s (a former #IVF doc turned portfolio manager) Special Situations Fund of AWM Investment Company increased to 11.1% or 1,154,153 share ownership of INVO Bioscience( INVO). They held 625k/6.5% as of the 13G filing 2-12-2021. If you are not familiar with them, I believe if you do a relatively small amount sleuthing you will find out that they are one of the most successful multi-billion funds over the last 20-years, especially when find small undiscovered microchips. I believe that they led the round of $13M at $3.20 a share in November 12, 202o that pushed INVO upmost to the NASDAQ. Here’s the 13G filing. 

• • INVO will report financial results for its first quarter 2021, ended March 31, 2021, after the market close on Monday, May 17, 2021. The Company has scheduled a conference call that same day, Monday, May 17, 2021, at 4:30 pm ET, to review the results. You can access the conference call by dialing 833-756-0861 or 412-317-5751. Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available in the Investor Relations section of the Company’s website at https://www.invobioscience.com/investors/ or https://www.webcaster4.com/Webcast/Page/2162/40939.

• • On May 10th, INVO announced the appointment of tenured women’s health & fertility solution marketing professional, Meryle Lynn Chamberlain, as Director of Marketing, a newly created position within the company. Chamberlain joined INVO Bioscience to spearhead and expand INVO Bioscience’s global marketing and brand management strategy for INVOcell, fertility care that is accessible, inclusive, and affordable to the more than 90% of couples in need of fertility treatment that currently go without care. Chamberlain brings over 15 years of marketing experience in the women’s health field including her most recent role as a Product Marketing Manager at Wildflower Health, a digital health company focused on women’s health and pregnancy and the Marketing Manager at The Emergency Nurses Association, an international healthcare organization, where she led integrated marketing strategies for all products, services and events. Ms. Chamberlain has a Bachelor of Arts degree in Political Science from Brigham Young University and the Integrated Marketing Certificate from DePaul University.

• • After the close April 26, INVO announced the appointment of Rebecca Messina to the Company’s board of directors. Ms. Messina has broad international experience in leading marketing for elite brands and businesses including Uber Technologies (UBER), Beam Suntory and The Coca-Cola Company (KO). She is currently a Senior Advisor at McKinsey & Company focused on advising internal teams and firm clients in the areas of marketing as a growth lever, including data driven marketing, brand building, and strategically shaping and transforming marketing agendas. Messina has also served as Global Chief Marketing Officer of Uber Technologies (UBER). As Uber’s first-ever CMO, Messina focused on executing Uber’s first global marketing organization, building a world class marketing network, with the mission of helping the company define a strong brand in the hearts and minds of all Uber stakeholders – furthering a movement around the possibilities of “progress for all” in a shared economy. Messina has been the recipient of a number of accolades, including: Forbes World’s Most Influential CMOs, 2019; Ad Age, Women to Watch 2016; Business Insider, Most Innovative CMOs in the World 2016; as well as serving on several boards including the Make-A-Wish Foundation.

• • On April 19, INVO announced the execution of a partnership agreement with Lyfe Medical, LLC (“Lyfe Medical”) focused on the expansion of the INVOcell solution in Northern California (with an area population of ~8 million people). “We believe that INVOcell can help address key infertility treatment industry challenges regarding cost & capacity constraints to help serve the very large underserved patient population. We are excited to sign this partnership agreement with the team at Lyfe Medical, a physician-led premier-level fertility practice, to establish an INVO center in the Northern California fertility market to help further our mission to increase access to care and expand fertility treatment across the globe. Lyfe has shown a strong commitment to bringing INVOcell into this region. We look forward to ramping up our respective requirements and begin operations later this year,” stated Steve Shum, CEO of INVO Bioscience. Please read the story here. 

• • On April 13,  I hosted INVO’s CEO Steve Shum at the Tribe Public CEO Presentation – Q&A Webinar Event where he delivered his presentation is titled “Democratizing Infertility – A Severely Underserved Global Market.” You may view the video of the event now at his link: https://youtu.be/w4yQIc7eO5k.

• • On March 30, INVO announced 2020 financial results and highlights.  Steve Shum, Chief Executive Officer of INVO Bioscience stated, “In the face of a difficult year for many industries, including the fertility business, I am extremely proud of the accomplishments of the entire INVO Bioscience team. During the year, we put in place a number of building blocks for the future, which are already beginning to pay dividends. Recently we announced our plan to open our first U.S.-based INVOcell clinic in partnership with some of the most highly accomplished INVOcell practitioners in the world. Our partners are not only extremely well-versed in the INVOcell technology, but also have a proven track record of successful implementation of the platform within an established clinical setting. A few months prior, we announced that we plan to open dedicated INVOcell clinics in Mexico with Dr. Francisco Arredondo and Dr. Ramiro Ramirez, who were also early adopters of the INVOcell solution and have established a successful track record of successful implementation of INVOcell in a clinical setting. We believe the combination of strong distribution partners such as Ferring in the U.S. and other locations around the world, coupled with dedicated INVOcell clinics partnerships which INVO Bioscience has an equity interest in, position the Company well for the future. Another key development during the year was the availability of additional positive real-world usage data highlighting the success of INVOcell, including a published peer-reviewed manuscript (report). We expect to see further data from this year’s SART information in the near future. In our opinion, this expanded retrospective, real world validated data is extremely valuable to our commercial efforts and builds confidence with practitioners. We believe that this expanding portfolio of usage data will play an important role in expanding and accelerating market adoption.”

• • On March 15, INVO announced the signing of a 50/50 joint venture agreement in partnership with reproductive specialists Dr. Nicholas Cataldo, MD, MPH, Dr. Karen R. Hammond, DNP, CRNP, and Lisa Ray, MS, ELD, to open the first Joint Venture INVO-exclusive clinic in the United States.

• • On March 8, INVO announced that they has agreed to an amendment of their agreement with Ferring Pharmaceuticals that provides for an increase in the number of INVO company-owned US-based clinics initially allowable under the agreement and removes certain geographical restrictions. The amendment also adjusted the remaining annual 2020 minimum contractual product purchase requirement, whereby Ferring will place a $501,000 order, which will be recognized as revenue by INVO Bioscience in the first quarter of 2021. READ STORY.

• • On March 1, INVO announced the Company has received approval by COFEPRIS to import INVOcell into Mexico. In late 2020, INVO Bioscience established a joint venture focused on establishing fertility centers dedicated to offering INVOcell, with the initial center, called Positib Fertility, to be located in the city of Monterrey, Mexico. Steve Shum, CEO of INVO Bioscience, commented, “We are extremely pleased to have received approval by COFEPRIS to begin importing INVOcell into Mexico. This was a key step in the process to open our first joint venture owned clinic in the large and growing Mexico market for infertility services. Our internal team along with our JV partners have and continue to work aggressively and with a relentless focus to bring the INVOcell treatment option to the many patients in need of care within Mexico.”

• • On Jan. 27, INVO announced that it has advanced its commercialization efforts into the European fertility market by securing initial orders of INVOcell in Madrid and Barcelona, Spain. INVOcell will initially be available at three separate existing fertility clinics which have placed orders and commenced training. Please read the story here.

• • Industry forecasts suggest that only 1% to 2% of the estimated 150 million infertile couples worldwide are currently being treated. INVO’s mission is to increase access to care and expand infertility treatment across the globe with a goal of improving patient affordability and industry capacity.

• Shares of Chinook Therapeutics (KDNY), a clinical-stage biotechnology company developing precision medicines for kidney diseases, closed today at $15.15, -3.99%.

• • On May 12, Chinook provided a business update and reported financial results for the first quarter ended March 31, 2021 today. Eric Dobmeier, president and chief executive officer of Chinook Therapeutics stated, “During the first quarter of 2021, Chinook made strong progress with its pipeline of programs for kidney diseases, including initiating the phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan, presenting encouraging clinical data from the BION-1301 program and entering into a strategic collaboration with Evotec. We are well-capitalized and resourced to execute across our programs to generate additional data catalysts and continue building Chinook into a leading kidney disease company.”

• • On April 15, Chinook announced six poster presentations at the ISN World Congress of Nephrology 2021 (WCN ’21). Eric Dobmeier, president and chief executive officer of Chinook stated, “The depth and breadth of our presence at this year’s WCN ’21 is a testament to Chinook’s role as a leading kidney disease company. Our data demonstrating BION-1301’s ability to significantly reduce Gd-IgA1 levels in healthy volunteers, as well as the favorable pharmacodynamics of subcutaneous administration of BION-1301, position the program well to move forward in demonstrating its disease-modifying potential for IgA nephropathy patients. In addition, our preclinical poster presentations on atrasentan provide broader insights into its anti-fibrotic and anti-inflammatory properties that are additive and complementary to its proteinuria-lowering mechanism of action.”

• • On April 15, Chinook’s CEO Eric Dobmeier  & CBO Tom Frohlich delivered a presentation titled “Revolutionizing The Treatment of Kidney Disease” followed by a Q&A session at the Tribe Public Network. You can view the video of the event here. 

• • On April 7, KDNY provided a business update and reported financial results for the full year ended December 31, 2020. Eric Dobmeier, President and chief executive officer of Chinook Therapeutics stated, “We are executing well on our goal of building Chinook into a leading kidney disease company. 2020 was a very busy and productive year, as we in-licensed atrasentan from AbbVie, closed a $115 million financing, brought BION-1301 into our pipeline through the merger with Aduro, unveiled CHK-336, our first internally-developed program, and bolstered our precision medicine discovery and research efforts. We are excited to have recently initiated our atrasentan phase 3 ALIGN and phase 2 AFFINITY trials and announced our collaboration with Evotec. We look forward to multiple data announcements from our BION-1301 program this year, as well as continuing to move CHK-336 towards the clinic. Our team has grown over 300 percent since the beginning of 2020, and we’re continuing to execute on our hiring plans to ensure we have strong resourcing in place to advance our pipeline. Our solid cash position, which we expect to fund our operations to the middle of 2023, enables us to achieve key milestones across our programs.”

• • On Monday, April 5th, KDNY announced a transaction with Van Herk Investments, a leading European life science investor, to create and fund a new company called Sairopa, with a pipeline focused on research and development of non-renal monoclonal antibodies generated through Aduro Biotech’s B-Select platform. Chinook will own approximately 40 percent of Sairopa after the first tranche of financing from Van Herk and have one seat on Sairopa’s Board of Directors.

• • On March 16, Chinook announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the ALIGN Study, a pivotal phase 3 clinical trial evaluating the efficacy and safety of atrasentan, a potent and selective inhibitor of the endothelin A receptor. “The initiation of the phase 3 ALIGN Study is an important milestone for Chinook as we advance our pipeline of programs for rare, severe chronic kidney diseases,” said Alan Glicklich, M.D., chief medical officer of Chinook. “Atrasentan has been studied in over 5,300 diabetic kidney disease patients in the phase 2 RADAR and phase 3 SONAR studies, demonstrating rapid, sustained proteinuria reductions of approximately 30 to 35 percent as well as improved eGFR. Importantly, treatment with atrasentan also resulted in a reduction in clinical outcomes of development of end-stage kidney disease and doubling of serum creatinine. We look forward to exploring the proteinuria-lowering, anti-inflammatory and anti-fibrotic effects of atrasentan in patients with IgA nephropathy, a serious progressive disease for which there are no approved therapies.”

  • On March 1, Chinook and Evotec SE announced a strategic collaboration focused on the discovery and development of novel precision medicine therapies for patients with chronic kidney diseases. Based on Evotec’s proprietary comprehensive molecular datasets from thousands of patients across chronic kidney diseases of multiple underlying etiologies, Chinook and Evotec will jointly identify, characterize and validate novel mechanisms and discover precision medicines for PKD, lupus nephritis, IgA nephropathy and other primary glomerular diseases. The collaboration will also involve further characterization of pathways and patient stratification strategies for programs currently in Chinook’s clinical and preclinical pipeline. “We are excited to embark on this strategic collaboration with Evotec, the leading drug discovery alliance and development partner in nephrology,” said Andrew King, D.V.M., Ph.D., Head of Renal Discovery and Translational Medicine at Chinook. “Gaining access to the NURTuRE cohort study and other proprietary patient biobanks, along with Evotec’s multi-omics integration platform, will enable us to define the molecular drivers of kidney diseases, identify novel targets for drug development in selected patient sub-populations and continue to build the foundation for our precision medicine approach. With a focus on comprehensive molecular disease classification, combined with prospective clinical outcomes, Chinook has the opportunity to potentially deliver targeted therapies to the right patient populations.”

• • On Feb. 2nd, Chinook announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA) for primary hyperoxaluria (PH). PH is a group (PH1, PH2 and PH3) of ultra-rare genetic diseases caused by enzyme mutations that result in excess oxalate production in the liver, and in its most severe forms, can lead to end-stage kidney disease at a young age. Inhibition of LDHA with CHK-336 allows for the potential to treat all forms of PH and other disorders arising from excess oxalate, while its liver-targeted tissue distribution profile enables maximal inhibition of liver oxalate production with minimal systemic exposure. Please read the story here.

• Shares of Seattle-based Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, closed at $2.46.

• • On May 11, Atossa announce that it urges stockholders to vote on proposals put forth in the proxy statement prior to the Company’s May 14, 2021 annual stockholder meeting. Atossa stockholders as of the March 24, 2021 record date may vote by calling (833) 786-6488 Monday through Friday 9 a.m. to 9 p.m. Eastern Time. Details of the proposals, the stockholder meeting, and additional information on how to vote your shares can be found in the proxy statement, found here. Holders of approximately 17.3 million shares of Atossa common stock as of the record date have entered into lock-up and voting agreements which require that they vote at the annual stockholder meeting.

• • On April 8, Atossa announced that an ovarian cancer patient has begun treatment with Atossa’s proprietary oral Endoxifen. The FDA previously issued a “Safe to Proceed” letter under their expanded access pathway, permitting the use of Atossa’s oral Endoxifen in this patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief. “The patient has recurrent ovarian cancer and did not tolerate tamoxifen, which is sometimes prescribed for ovarian cancer as well as breast cancer,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “The patient recently underwent functional molecular genomic testing using 3D tumor organoid cultures grown in the laboratory from the patient’s tumor to help determine potential therapies. This testing revealed that the combination of Endoxifen and alpelisib produced an exceptional tumor response. We will follow the progress of this patient and consider additional clinical studies in patients with ovarian cancer.” Under the FDA expanded access program, the use of Atossa’s proprietary oral Endoxifen is restricted solely to this patient.

• • On March 31, Atossa announced their financial results for the fiscal year ended December 31, 2020, and provided an update on recent company developments. Read the complete story. 

• • On March 22, Atossa  announced that it had entered into a securities purchase agreement with institutional investors to purchase $50 million of its shares of common stock and warrants in a registered direct offering priced at-the-market under Nasdaq rules. Read the complete story.  Atossa has now raised ~$141M in gross proceeds (via registered directs and warrant exercises) since Dec. 2020 affording the company a significant development runway and many more options to be considering including acquisitions. 

• • On March 11, Atossa announced the FDA has issued a “Safe to Proceed” letter under their Expanded Access Pathway, permitting the use of Atossa’s oral Endoxifen as a treatment in an ovarian cancer patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief. Under the FDA expanded access program, the use of Atossa’s proprietary oral Endoxifen is restricted solely to this patient. Approval from the Institutional Review Board (IRB) must be obtained prior to providing oral Endoxifen to this patient. Read the complete story.

• • On Feb. 25, Atossa announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home. Steven Quay, M.D., Ph.D., Atossa’s President and CEO stated, “The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301. We recently received input from the FDA on this program and based in part on that input, we are now preparing to conduct an additional pre-clinical study, which we expect to start this quarter. Following that, we expect to apply to the FDA to commence a Phase 2 study here in the United States.”