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Re: HyGro post# 546989

Saturday, 12/10/2022 11:00:56 PM

Saturday, December 10, 2022 11:00:56 PM

Post# of 822756
HyGro,

You do know that Padur's paper was referred in the JAMA paper.
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

Since you always conjecture that FDA will not grant approval on murcidencel, is it reasonable for us longs to think once that JAMA was postponed for such a long time simply waiting for FDA to finish the regulatory preparation?

You are right that FDA will review a lot more data than reviewers of the paper. You do remember the expansion program of dcvax for compassionate use. FDA for sure will have plenty data for many individual cases. IMHO, the conclusion from these data can be only be good.

https://clinicaltrials.gov/ct2/show/NCT02146066

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