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What's Next Seems like AVXL has some clear next steps 1. Get full results published in respected medical journal. That could take 3+ months so I'm not expecting any further data until that is published, but it should strengthen efficacy claims (especially high dose cohort) 2. FDA Meeting: Even with positive efficacy and safety profile that should only get stronger over time, I don't see FDA granting approval until a more definitive P3 study is completed. IMO it will likely be 2024-25 before approval (disappointing but probably realistic - especially after Aduhelm fiasco). Possible to get Accelerated Approval pending confimratory P3 (similar to what IMGN just received), which might allow for approval late '23/early '24. 3. Biggest highlight from today seems to be their patient group had more advanced dementia than Biogen/Lilly studies and still showed great results. Really confirms this works without the safety concerns and will actually demonstrate clinically meaningful improvement in cognition for some (Dr Perry :46 on today's call). a) At 48:30 BTIG asks about % patients who improved over their baseline. Missling gave a vague answer but confirmed a number of patients did improve over baseline in addition to placebo - that is huge! Slowing decline is one thing but demonstrating improvement is way better. 4. Given likely need for another study and clear superiority to Biogen/Lilly drugs, AVXL will likely enter partnership with major pharma, but that may be 4-6 months out. Agree ROW might focus on Japan and Australia which may come before US approval. So while I will stay long and wiil buy on dips, I will be patient, as we may not see much pps appreciation for several months... |
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Msg # | Subject | Author | Recs | Date Posted |
3710 | Re: What's Next | eagle76 | 1 | 12/6/2022 4:24:41 AM |