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Jake,
Just because they don't have a partnership now doesn't mean they won't have down the line. The best case scenarios still see P3 starting by the end of the year.
It's just that when you balance out all the things that could go wrong with a more ideal time line and great results, there isn't anything there right now.
dewophile is presenting something towards the best case. He is certainly allowed to do that! I'm reserving my right to change my mind if I see partnership and trial details that I like. In the meantime, they have managed to show that some people who would have gotten better anyhow got a little faster relief on some symptoms taking the 400 mg dose.
Tamiflu is still on the market?
ENTA
Thanks for the input.
That eliminates AZN's interest in the US.
Not sure if/how that might affect the partnership going forward given the China interest.
XRAY
ISEE bought
Astellas Enters into Definitive Agreement
to Acquire Iveric Bio
https://www.astellas.com/en/system/files/news/2023-05/20230501_Press%20Release%20final_EG.pdf
presumably one or both of these:
https://clinicaltrials.gov/ct2/results?term=fibrogen&cond=IPF&age_v=&gndr=&type=&rslt=&phase=1&Search=Apply
It's Cowen's note. I'm just reporting and don't have Cowen's note.
Re: FGEN drop
Martin Shkrelli launches healthcare AI - Dr Gupta.Ai
https://martinshkreli.substack.com/p/introducing-drguptaai
PHG
https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-dreamstation-cpap-bipap-machines-risk-they-may-deliver
Another Class 1 recall, affecting some of the reworked DreamStation machines they gave out as replacements in the original recall. Only 1088 devices were affected. Price has in the meantime crept up to the 18's. Well above the lows of around 12 and well below the pre-recall highs above 60.
BIIB, et al
Interesting note by Derek Lowe on anti-amyloid and brain shrinkage.
https://www.science.org/content/blog-post/are-anti-amyloid-antibodes-going-make-alzheimer-s-patients-worse
That's all pretty standard.
What is your view (in retrospect, of course) about the timing of the resignation just before the RETA decision? Did avoiding (or minimizing, or not being affected by) that controversy ease his transition? Any other comments on reflection?
TIA
The word that comes to mind is egregious.
Beyond that everything is a matter of opinion and nuance.
Re Dunn done...
Resignation effective immediately.
Teresa Buracchio will be acting director of FDA's Office of Neuroscience.
Most interesting immediate 'test case' appears to be RETA.
Congrats to all holders. (no position)
ISEE next?
GSK gets Dapro approval. DD only. I haven't looked at the label.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis
TTNP
PHG
Continues to have issues handling recalls. Price has recently rebounded from about 12 to currently around 14, still well down from 2021 highs above 60. Part of the rebound may or may not be attributed to the savings realized by choosing to offer $25 or $50 for the return of some older recalled machines instead of repairing them, a cost and logistics saving (plus one less potential FDA issue, lol.)
All I can do is point you towards reporting from what Dr. Chambers has said recently in public. If the FDA goes back to in-person meetings then ADCOMS may be held, but not until then.
https://twitter.com/sentivcapital/status/1576667386656145410
I thought I had the statement on video from the conference but cannot find the bookmark.
APLS
FDA approval decision for Apellis Pharma’s eye disease drug delayed to review more clinical data.(24 month data)
The review period was extended three months.
PHG
" and now... (in the third quarter) we also have become loss-making,"
https://www.reuters.com/business/philips-cut-4000-jobs-after-medical-equipment-recall-2022-10-24/
LOL
The market and the regulators have the last word. :)
I was hearing the same 1 billion numbers for FGEN. I think it is safe to assume GSK will be approved in the EU where FGEN is already selling, and they will split the HIF market in some fashion (no need to debate who gets how much, not the point.) The overall market should expand though.
Another less encouraging article from Fierce.
https://www.fiercepharma.com/pharma/fda-adcomm-votes-benefits-outweigh-risks-gsks-daprodustat-treat-patients-dialysis-its-no
The value in NDD is if it allows a significant population, since there shouldn't be a pricing difference between DD and NDD. Getting any approval - even if highly restricted - is a good thing but may not make enough difference to the bottom line to move the stock unless it applies to more than a fairly limited subset of NDD. Obviously a broad label in NDD would be a homerun. I don't see that happening, a fairly restricted label is clearly possible (FDA can do anything) but looks less than what you suggest.
By itself DD is harder to quantify since it has the potential to take a large share over time, and a larger population over time as well. Agree that it is more likely than not there is an approval, label and post market requirements pending. Some kind of additional data before approval not out of the question but not necessarily significant.
It does look like most of the negative perception has washed out of the stock at this point but I wouldn't be surprised to see it test the September lows again even if there is no more negative news. I don't have an opinion on what the value of the stock is.
Packer was with the majority on both votes.
Watch Packer. He will be the biggest obstacle/hardest to convince.
PHG
How about a sticky post that links all the prior sticky posts, or similar?
Ok.