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TheDane

01/14/21 9:01 AM

#339746 RE: BonelessCat #339735

Thanks. It makes perfect sense that he had to wait for that reason but I did enjoy imagining it was because of a deal being worked out.

leavetheguntakethecannolis

01/14/21 9:07 AM

#339751 RE: BonelessCat #339735

Definitely sounds like our government in action.

"The fast track after approval would cause great delay".

loanranger

01/14/21 9:32 AM

#339768 RE: BonelessCat #339735

Are you saying that the Fast Track program, if granted after the start of the trial, would actually slow the trial down?

It sounds like the program incorporates remedies for such things:
"A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers"


"The final trial protocol must include the plan under fast track."
Sounds like the FT program provides flexibility, not that the proposed final trial protocol is etched in stone.