So you agree? N values have undoubtedly improved with real world evidence of at least 70 plus patients and more likely around 100. I am sure that the N values of your stuff has also improved.
Your comments in regards to 001. I believe the FDA has ruled on this. The win component of BLA 2, NO LONGER DO THE FDA QUESTION EFFICACY OF 001.
"distinguishing between anecdote and real world evidence"
Thats why we have the FDA , They didn't do such a good job when we now look at the ODAC notes of the first BLA , indeed the 9-1 vote must have been a wake up call.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-605
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