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loanranger

12/16/18 8:48 AM

#251450 RE: BonelessCat #251447

You're responding to a person who expressed this opinion...
"The FDA has 30 days to send out the minutes and in the interim, it’s foolish to issue any press release mentioning details about the meeting."
....but I can't quite tell whether you're agreeing or disagreeing with that opinion.


IF...."The CEO will know at the end of the meeting those conditions and designations the FDA has approved. He will be able to report that the E-o-P 2 meeting was successful and that B-OM will advance to Phase 3. He will also be able to report such things as fast-track or any other elements of accelerated approval agreed upon. He may even be able to include any other designation accepted, but not details."
....would you expect a press release reporting those things to be issued at the end of the meeting?


(BTW as far as I know there is no expiration date for a Fast Track Designation. The Sponsor or the Agency may withdraw fast track designation if the designation is no longer supported by emerging data or the drug development program is no longer being pursued and I don't think either of those things has happened. https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf )