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DR5

04/04/24 4:42 PM

#13408 RE: Pragmatic D #13407

Yes, that’s true but it doesn’t take into consideration the new eStar submission platform. So, I did some investigating of eStar and my impression is that eStar is a comprehensive submission platform that doesn’t allow the submitting company to be less than complete with everything that is needed in order to fulfill the requirements for approval.

After going through a dozen presentations of eStar, I feel that the submission will get a quick turnaround on the necessary info needed to green light the full review. My expectation of approval, if it’s coming …and, I personally think so, is mid to late May …or sooner. I really don’t think the decision from the FDA will go beyond 3 months from 3/21. That’s my educated guess.GLTA!

Waverunners

04/05/24 11:41 AM

#13430 RE: Pragmatic D #13407

Pragmatic, you nailed it here. You were accurate and strong in your opinion.
Then you folded like a cheap suit.
Why would dr5 ever ever ever have more insight than what you offered.
He took your accurate information and ran it through the dr5 make believe machine.

You were right. He (of course) was wrong.

Pragmatic D

05/03/24 11:41 AM

#13610 RE: Pragmatic D #13407

Yesterday marked 6 weeks from when UEEC reported that the application was submitted. The FDA has 45 days to review the application, so UEEC should hear something from the FDA by Tuesday at the latest.