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Re: Pattyloco post# 755940

Sunday, 03/23/2025 4:25:00 PM

Sunday, March 23, 2025 4:25:00 PM

Post# of 828417
There is no way to convince you the timeline for (assumed) approval has not been abhorrent and disappointing. LP stated biotech investing, including venture capital, is not for the faint of heart.

Personally, I find the process completely revolting, but the MAA, according to at least a few well regarded posters, still has a pulse and
is, from looking at averages, still within a typical approval window for this type of technology. One DD guru puts May 6 or 7 as his worry date, if no approval on or before that time.

I won’t be posting here after April 7 if no approval by then. One thing that bothers me immensely about the process is that despite the fact the agency knows this technology inside and out, the agency has supposedly highly prioritized this cancer indication, supposedly prioritized this amazing and unprecedented type of safety profile, know its potential, understand its impact on long term survival, have over a decade experience with the therapy in compassionate treatment, picked through and certified all relevant manufacturing, understand patient need, and despite all that, they’re incredibly slow.

Patients are waiting.
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