This is where all my skepticism stems from.
FDA requests more evidence of efficacy.
MSB doesn't provide and gets CRL again.
In this CRL they say they will do another trial in adults to address concerns.
Now they're reapplying after not doing it, again.
I know I'm repeating myself - because some people don't seem to be able to follow.
It's pretty simple.
No point beating a dead horse tho. Time will tell.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-272
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