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dydo

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Everything posted by dydo

  1. If it goes to $22, what does it matter?
  2. a news just came across https://finance.yahoo.com/news/esperion-announces-publication-journal-american-151224485.html
  3. new article https://seekingalpha.com/article/4355770-esperion-therapeutics-easy-double-maybe-lot presentation https://seekingalpha.com/article/4348809-esperion-therapeutics-espr-investor-presentation-slideshow
  4. Hello, a new conviction pick, Esperion Therapeutics, Inc. (ESPR), brand new medications for the cholesterol, coming on the market in the US and EU. The company has about 30M shares, worth today $1.4B, sales potential of $1B., Price target $150, trades at $53
  5. I think I would agree. Lack of the catalyst, dictates price in this situation. I think $7 is likely. I have folded my position. Own MEIP and SELB.
  6. dydo

    Beyond Solar

    I bought company called MEI Pharma symbol is MEIP, I think it is worth at least $10 but trades around $4.30, good luck.
  7. BABYF release news on production of samples yesterday https://finance.yahoo.com/news/else-nutrition-announces-u-launch-110000651.html
  8. dydo

    Beyond Solar

    Another interesting situation is a company called TAAT Link to a company's website. https://taatusa.com/ It started trading yesterday on CSE. As far as I can tell it does not have US pink sheets symbol. We are talking a grass root start up and entry. I have few shares. It is likely like a BABYF but 6 months ago. Use your own DD.
  9. Hi Marty, Yes, the result was not what was expected. BioMarin’s median level of the factor at year one was 60. At 28 weeks, Pfizer looks to me like that is patient #10, tracking over 60, then you have week 36, patient #11 is not there, leaving it between #7 and #10. 7 is way up there close to 125, while 10 slipped below 50. It appears to me when all hit a year, the 60 achieved by BioMarin will be better because #10 is becoming a median and has fallen under 50.So the only better is hopefully no bleeds. There is also a tremendous amount of variable. Of course, nobody knows what variable was for BMRN. The ALT episodes seem to drop the activity. If there is steroid use, perhaps it can regulate levels of factor avoiding drops, but if one does not need it, since no bleeds or need for replacement, then why bother.The stock sold on unmet expectations, forgetting it is up to Pfizer, to design phase 3, and come up with perhaps even a higher dose and use of steroids to prevent the reduction of factor activity. Also, the lead-in study could answer questions on what characteristics of a patient the treatment would have the most success. I think, since the AFFINE showed up at the end of April and updated in May, Pfizer/Sangamo knew March results already. The decision to start in July was based on the update we saw Thursday. I think this is positive, as Pfizer can manage the design, and they have trial experience and resources surpassing Sangamo. I imagine September all are over 52 weeks; likely December ASH will be the forum to discuss it. We will not know what Pfizer is doing in phase 3; nobody knows what is happening to hemophilia B, so I see no difference here. Do you see anything else come up between now and then? I assumed all trials would be postponed.I also think that ZFN 2.0 is not happening. Ed Rebar was leaving, and I cannot think of any other reason but everyone focusing on Biogen and moving resources away from MPS II. The indication is missing from the corporate deck. I imagine Sangamo is going after diseases with significant prevalence. So cell edit and gene regulation will be the action. I doubt we will see gene therapy either, beyond Fabry. Gene therapy is not ZFN, and the company is ZFN. It makes sense to focus on those. Small genetic diseases are too expensive to address with the budgets of Sangamo.
  10. I guess they got me at hydrogen,
  11. I found this company couple of days ago. Since I am invested in SGMO, I found interesting for them to enable re-dosing of AAV vectors. A huge obstacle as gene therapy is a one time condition. They have also signed a deal with Sobi, huge Swedish biotech company, got $100M and dropped like 30%. So I bought it, two days ago.
  12. Nice move today, I wish we knew more about the company. @ghouston can you provide a view why this is a good investment? Thanks
  13. Expecting news release next week, nicely consolidating around $1.50 US, good base for some stronger runs after the news.
  14. Hi there, I created the forum. If you are interested in providing the content, go ahead.
  15. But the stock is oversold. Pfizer will make the treatment work. Start of P3 will pay SGMO, and they also said they will try to accelerate. While I am not seeing bets in class, I flipped back to have SGMO at low 9s.
  16. I have not specific plans. There is so much needed to reach 7, that speaking about this as a target in mind is not value- added. for start $100M in sales. It was an example of course to illustrate the potential. The company is holding all pieces. News, progress measure will drive the price and my ability to evaluate. I hope this helps.
  17. I share the sentiment. From best in class to meh. Very little between now and anything internal. P 3 till 2022 and marketing perhaps in 2023.
  18. PR from Pfizer https://finance.yahoo.com/news/pfizer-sangamo-announce-updated-phase-130000978.html — Dosing of the first patient in the pivotal Phase 3 study anticipated in second half of 2020 — Pfizer Inc. (NYSE:PFE) and Sangamo Therapeutics, Inc. (Nasdaq:SGMO), a genomic medicines company, today announced updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec (SB-525, or PF-07055480), an investigational gene therapy for patients with severe hemophilia A. All five patients with severe hemophilia A who received the 3e13 vg/kg dose showed sustained factor VIII (FVIII) activity levels, with a median of 64.2% via chromogenic assay (patient-level geometric means after week 9 post-infusion). No patients experienced bleeding events or required FVIII infusions. The factor VIII activity levels reflect measurements up to 61 weeks, the extent of follow-up for the longest-treated patient in the cohort. These data are being presented today as a late-breaking oral abstract at the World Federation of Hemophilia 2020 World Congress, which is being held virtually from June 14 to June 19, 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200618005091/en/ Giroctocogene fitelparvovec was generally well tolerated. As previously reported, one patient in the 3e13 vg/kg dose cohort had a treatment-related serious adverse event of hypotension (grade 3) and fever (grade 2), with symptoms of headache and tachycardia, which occurred six hours post-infusion with giroctocogene fitelparvovec, and which fully resolved within 24 hours. No other treatment-related serious adverse events were reported. Among the five patients in the 3e13 vg/kg dose cohort, four received corticosteroids for liver enzyme (alanine aminotransferase, ALT) elevations. Three patients had subsequent ALT elevations that responded to corticosteroids. All episodes of ALT elevations fully resolved with oral corticosteroids. "We are excited that these data affirm previous findings from this Phase 1/2 study, and that all five patients have sustained levels of factor VIII activity with no bleeding events or use of factor replacement therapy. We are encouraged by the potential of giroctocogene fitelparvovec to demonstrate longer-term durability, an important element for patients living with severe hemophilia A," said Seng Cheng, Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Disease Research Unit. "The Phase 3 lead in study is ongoing, and we look forward to dosing patients with this investigational gene therapy in the pivotal Phase 3 trial later this year." "The current standard of care for severe hemophilia A requires regular infusions to replace missing Factor VIII. Gene therapy, on the other hand, offers a new approach with the potential to provide a one-time treatment that would enable patients to produce the missing factor on their own," said Bettina M. Cockroft, M.D., M.B.A., Chief Medical Officer of Sangamo. "These follow-up data indicate that treatment with giroctocogene fitelparvovec resulted in sustained factor levels up to 14 months following treatment and suggests the potential of this investigational gene therapy to alleviate the treatment burden of current hemophilia disease management." The additional follow-up builds on data presented at the 61st Annual Meeting of the American Society of Hematology (ASH) in December 2019, which demonstrated that giroctocogene fitelparvovec was generally well tolerated and resulted in sustained FVIII levels up to 44 weeks, the extent of follow-up for the longest-treated patient in the 3e13 vg/kg dose cohort at that time. The previously presented data included 11 patients treated across four ascending dose cohorts: 9e11 vg/kg (2 patients), 2e12 vg/kg (2 patients), 1e13 vg/kg (2 patients) and 3e13 vg/kg (5 patients). Pfizer and Sangamo plan to present further follow-up data from the Alta study when all five patients in the 3e13 vg/kg dose cohort have been followed for at least one year. About the Alta study The Phase 1/2 Alta study is an open-label, dose-ranging, multicenter clinical trial designed to assess the safety and tolerability of giroctocogene fitelparvovec in patients with severe hemophilia A. The mean age of the 11 patients assessed across four dose cohorts is 30 years (range 18-47 years). All 11 patients are male. The U.S. Food and Drug Administration has granted Orphan Drug, Fast Track, and regenerative medicine advanced therapy (RMAT) designations to giroctocogene fitelparvovec, which also received Orphan Medicinal Product designation from the European Medicines Agency. Giroctocogene fitelparvovec is being developed as part of a collaboration agreement for the global development and commercialization of gene therapies for hemophilia A between Sangamo and Pfizer. About giroctocogene fitelparvovec Giroctocogene fitelparvovec (SB-525 or PF-07055480), comprises a recombinant adeno-associated virus serotype 6 vector (AAV6) encoding the complementary deoxyribonucleic acid for B domain deleted human FVIII. The giroctocogene fitelparvovec expression cassette was designed for optimal liver-specific expression of FVIII protein and supports production of high yields of the vector. The giroctocogene fitelparvovec transcriptional cassette incorporates multi-factorial modifications to the liver-specific promoter module, FVIII transgene, synthetic polyadenylation signal and vector backbone sequence. In late 2019, Sangamo transferred the manufacturing technology and the Investigational New Drug (IND) application to Pfizer. Pfizer is enrolling patients in the Phase 3 lead-in study (ClinicalTrials.gov Identifier: NCT03587116), the data from which is expected to provide a baseline for patients who are subsequently enrolled into the pivotal Phase 3 study (ClinicalTrials.gov Identifier: NCT04370054). The primary endpoint of the Phase 3 study is annualized bleeding rate (ABR) over 12 months, and secondary endpoints include steady state FVIII activity levels, annualized infusion rate of exogenous FVIII activity, annualized FVIII consumption, ABR and total ABR of specific type by cause and by location, and change in joint health using Hemophilia Joint Health Score, over 12 months.
  19. Those who like to get SEDAR download of MDA it is here Else Nutrition MDA.pdf
  20. @CallmeD I was asking about the CEDAR, because I was curious about the warrants. I noticed a large amount of warrants, but did not get to the part actually but recently. They are not cash warrants meaning that many shares will be issued to owners. That 131M amount of shares includes them but there is no money for them. I learn this is actual listing transaction where owners wanted to avoid taxes, so they split their original stake into shares and warrants. Like the performance goals including revenue and seeing $60M is really exciting. Finally big chunk is infant formula, which requires FDA approval, trial etc. SO owners chose to show performance criteria before they got half of their initial stake. That is great. Warrants as of December 31, 2019 On June 12, 2019, the Company granted 31,801,492 warrants to key persons and founders (“Key Person Warrant”). Each Key Person Warrant entitles the holder to receive a common share of the Company at nominal price of $0.0001 per share which is exercisable for a period of three years following the achievement of following exercise events:•32.3% exercisable upon receipt of either: (A) FDA or equivalent regulatory approval in the U.S. or (B) any other equivalent regulatory approval in any other primary large market (including any of the markets in European Union, UK, Canada, Australia, Japan, or China) permitting a product based on the intellectual property pertaining to a plant-based, non-dairy formulation to be sold or marketed as an infant formula (up to 12 months of age) or baby formula;•17.3% exercisable upon the Company, together with its affiliates, generating $10M in top line revenue on a consolidated basis achieved in any consecutive 12-month period;•25.2% of the Else Key Person Warrants will be exercisable upon the Company, together with its affiliates, generating $20M in top line revenue on a consolidated basis achieved in any consecutive 12-month period; and•25.2% of the Else Key Person Warrants will be exercisable upon the Company, together with its affiliates, generating $60M in top line revenue on a consolidated basis achieved in any consecutive 12-month period. Any unvested Key Person Warrants automatically expire on June12, 2024 if the above exercise events have not occurred. As of the date of this MD&A, no Key Person Warrants have vested
  21. Fraud allegations I read on SA. Crazy selloff
  22. A bit mad out there today. Over 5M shares traded on both sides of the border. 10% down. Reality check stock is up 93% since I wrote about. It was coming but nobody knew when. There is a shift in the base and selling indicates some folks had enough of holding. There were as many buyers. I think an update on sampling orders would have done well today, but samples seem to go out only next week. The news is also due next week. It could be samples but I hope it is more. I think we are on pause. Still next two days should be green, in my opinion. GLA
  23. Pretty powerful pullback, 6 days of straight up, no surprise.
  24. Based on the interview with the CEO, The Frankfurt listing is in the direct interest to address European market. She said France is an objective for distribution by H&H. If you recall H&H acquired rights for China, France and Italy and other locations. I think Australia as well. Biostime is their brand. I think they will do awesome job distributing Else product.
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