Replies to post #105359 on Biotech Values

[RockRat]

"There have been myriad cases where the FDA inspected an applicant’s plants and ended up not approving the drug on the current review cycle."

Yeah, I was wondering about how common that was. And how common it was when the applicant passed the inspections. I agree with your bottom line, and thus I think the odds of tEnoxaparin being approved in the near to intermediate term have improved slightly.

I think I'm done with subject for now.

Regards, RockRat

[zipjet]

There have been myriad cases where the FDA inspected an applicant’s plants and ended up not approving the drug in question on the current review cycle.

IF TRUE, that largely negates the assertion that FDA would not bother to inspect unless they were nearing approval and the inference of near-term approval.

ij

PS, The "if" statement is not an indication of non-belief. Like Schultz, "I know nothing, nothing ..."

PSS - Thanks RockRat.