Replying to Reg https://hotcopper.com.au/posts/75086866/single...

Replying to Reg
https://hotcopper.com.au/posts/75086866/single

"3. Clear failure to include evidence of effectiveness compatible with statute and regulations, for example:
a) Lack of any adequate and well-controlled clinical trials, including use of obviously inappropriate or clinically irrelevant study"

What is the chances that the FDA has opened the door to a BLA for the third time and have again overlooked the above grounds for refusing to accept the BLA ? CRL 2 was all about this.
The FDA have accepted the BLA.
Would this mean that the reason given in CRL 2 , failure to include evidence of effectiveness compatible with statute and regulations, would have been checked and checked again and again. Pre BLA meeting , general check of BLA and then again to see if we have adressed the CRL 2 issues.