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Re: Maverick0408 post# 454402

Friday, 03/25/2022 8:30:49 PM

Friday, March 25, 2022 8:30:49 PM

Post# of 700520
Mav,

I could believe that a company might wait to submit a BLA to a regulator prior to revealing TLD, but not that they could wait for a decision from them. In fact once submission is made a PDUFA date should be established, no one would hold the TLD statement that far.

I think it would be outstanding if in the TLD statement we learned that the BLA's is about to be submitted to anywhere from one to all four regulators. I think they should be close, the question is whether they wait for FlaskWorks certification, or work to achieve that in the period between submission and approval.

I believe we'll have something to talk about by ASCO, and even if we don't make a formal presentation there we'll be a hit of the conference.

Gary
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