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Re: None

Wednesday, 05/05/2021 1:45:17 PM

Wednesday, May 05, 2021 1:45:17 PM

Post# of 16704
Interestingly enough...I'm having one helluva time trying to find ANY biotech company that reported news of their intent "to file" an EOP2 meeting request with FDA. What I can find is many companies reporting results of their EOP2 meeting. ALL that I've looked at, Blue Whales and everything else, simply do not have an announcement of a pending meeting in their news release archive. It's a very puzzling thing given AP has given us 2 news releases thus far prior to the actual meeting. Here is one company I found with a timeline from the time they announced their phase 1/2 clinical trial data to the time they announced positive results from their EOP2 meeting.

The timeline would suggest Bioniz Therapeutics filed for an EOP2 meeting at some point in December 2020 and their meeting happened within 30 days of filing the request. The below example isn't even COVID-19 related, so I'm not sure if the example even falls into an expedited category. Meaning, a COVID-19 related request could possibly be within weeks (1-4) not months (1-2):

DEC 05, 2020, 10:30 ET
Bioniz Announces Positive Clinical Data of BNZ-1, First Anti-Cytokine Therapy to Demonstrate Efficacy in Treating Refractory Cutaneous T-Cell Lymphoma

JAN 04, 2021, 09:00 ET
Bioniz Announces Positive End of Phase 2 Meeting with the FDA for BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma


www.prnewswire.com/news/bioniz-therapeutics%2C-inc./

Just a thought,

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