Look up the low percentage of companies that get RTF, the length of time it takes to refile a BLA and the percentage of drugs that get an RTF and THEN obtain subsequent approval. The odds are bleak.
Info is available if you check.
An RTF is A MAJOR EMBARRASSMENT!
The FDA will signal your failures by the questions you get on the BLA. Having a substandard CRO, Amarex, and an obtuse CEO are recipes for disaster.
An experienced pharma team would have seen the signals and pulled the submission. Check with top pharma people…I did. No armchair quarterbacking here. I speak with people in the industry who are presently conducting trials.
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