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You obviously didn’t read any of the materials produced from the workshop… they stated that in using eGFR as the primary endpoint is impractical because it would require >500 patients PER ARM to detect even a modest 1 mL/min/1.73m^2/yr difference. In duplex study n was 371 TOTAL.
So no, this trial was not “large and long enough to see a difference” lol.
Laura Damashek, the founding Executive Director of the Int’l. Society of Glomerular Disease, specifically stated “the data from PARASOL suggest that those trials (DUET and DUPLEX) would have been underpowered to detect a GFR slope difference in FSGS within the study timeline.”
*“But of course non expert retail investors will try to point to signs such as "why wouldn't they issue the CRL earlier, why extend it".”* You say this to sound intelligent but are unfamiliar with the fact that nearly 90% of applications that have approval decisions pushed out by 3 months ultimately get approved. So no, it doesn’t alone mean they are going to approve it - but it does show a willingness of CDER to work with TVTX towards an approval and directly contradicts your CRL thesis which is simply that it failed on the primary endpoint.
Aliza Thompson has been at the FDA for nearly 20 years and is a very respected director at CDER and was a prominent member of the PARASOL group, so while you may “not care about parasol,” their findings and conclusions will be a huge factor in this decision.
I am not sure why you are calling people “non expert retail investors” when that is clearly exactly what you are as well. And I can easily tell that because it’s clear you haven’t been able to access, read, or hear any of the buy-side or credible sell-side views on this application/ decision. On the sell-side, Guggenheim, Leerink, TDC, JPM, Wells Fargo, Jefferies, Citigroup, and many others have given PoS%s between 75-85%. On the buy-side, the specialist biopharma HF PMs that follow/ own TVTX are bullish on the decision. I know many of them. Several of which have been amongst the best performers of all biotech specialists over the last 2-5 years.

You obviously didn’t read any of the materials produced from the workshop… they stated that in using eGFR as the primary endpoint is impractical because it would require >500 patients PER ARM to detect even a modest 1 mL/min/1.73m^2/yr difference. In duplex study n was 371 TOTAL.
So no, this trial was not “large and long enough to see a difference” lol.
Laura Damashek, the founding Executive Director of the Int’l. Society of Glomerular Disease, specifically stated “the data from PARASOL suggest that those trials (DUET and DUPLEX) would have been underpowered to detect a GFR slope difference in FSGS within the study timeline.”
*“But of course non expert retail investors will try to point to signs such as "why wouldn't they issue the CRL earlier, why extend it".”* You say this to sound intelligent but are unfamiliar with the fact that nearly 90% of applications that have approval decisions pushed out by 3 months ultimately get approved. So no, it doesn’t alone mean they are going to approve it - but it does show a willingness of CDER to work with TVTX towards an approval and directly contradicts your CRL thesis which is simply that it failed on the primary endpoint.
Aliza Thompson has been at the FDA for nearly 20 years and is a very respected director at CDER and was a prominent member of the PARASOL group, so while you may “not care about parasol,” their findings and conclusions will be a huge factor in this decision.
I am not sure why you are calling people “non expert retail investors” when that is clearly exactly what you are as well. And I can easily tell that because it’s clear you haven’t been able to access, read, or hear any of the buy-side or credible sell-side views on this application/ decision. On the sell-side, Guggenheim, Leerink, TDC, JPM, Wells Fargo, Jefferies, Citigroup, and many others have given PoS%s between 75-85%. On the buy-side, the specialist biopharma HF PMs that follow/ own TVTX are bullish on the decision. I know many of them. Several of which have been amongst the best performers of all biotech specialists over the last 2-5 years.