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underpar71

05/21/24 8:58 AM

#692906 RE: dennisdave #692904

It's definitely not March 7th but also not likely Jan 24th. Probably a few days to a week after Jan 24. I am going with FEB 1st. 150+60 is around end of August....

antihama

05/21/24 3:45 PM

#693051 RE: dennisdave #692904

Ok, that makes sense but there is a reason they provided 2 dates and as deepthought noted via DoubleJ23 post 691530 from his/her discussion w NWBO.

Neither January 24th nor March 7th is the start of the clock. More like somewhere in between. That's where the 80 days begin...

So, assuming an RFI, approval would be between Aug 21 and Oct 3. I am not buying the clock started on Jan 24th though because why did they provide the notification it had passed validation of Jan 24th and notification the validation was confirmed on March 7th. You only needed to provide 1 date as the Outlook Therapeutics example showed. There is a reason they provided 2 dates and that is the clock started ticking somewhere in between. There was no other reason to provide 2 dates as the Outlook example showed.

In sum, approval after 150 plus 60 days is somewhere between Aug 21st and Oct 3rd, if no RFI, approval would be between June 22nd and Aug 4th. I saw your response to underpar71 but I’m not changing my mind that the approval clock starting ticking somewhere between the date it passed validation and the date validation was confirmed. We’ll have to disagree on that but man I hope your right.