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