Respectfully, I'm not getting your point about being concerned that the placebo arms in other trials outperformed relyvrio in CENTAUR. Yes, placebo rates will be different across different trials in almost every indication. To me,... login to read the rest
I suspect significant holdings bought on the IPO in anticipation of the PDUFA on June 29th and are waiting until then. The prospectus strongly implies that approval is a foregone conclusion which is extremely misleading... login to read the rest
Agree. I should have been more specific in the description. Afaik briefing docs are not released until 2 days before the adcom which is still months away.
Thank you for the reply. For waht it's worth, I think the real catalyst here is the PDUFA, which you expect to result in a CRL. If that's the case, I think it will be... login to read the rest
The dates are accurate. I don't see how approval can be given before P3 trials given how extremely weak the P2 was and the history of the disease. I expect a CRL and insignificant P3... login to read the rest
My understanding is that AMX0035 has a PDUFA date of June 29 2022 while the P3 trial doesn't read out until 2024. Is that right? If so, wouldn't the umportant upcoming catalyst here be either approval... login to read the rest
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