This is good info to recall to maybe modify ques

This is good info to recall to maybe modify questions. For example for BLA Part 3 (CMC) apparently something the FDA needs to do will determine the filing date. Likewise with dose safety data question

Maybe for that one, change or possible add

Any feedback from the FDA after informing them 525mg was the planned dose?


Also for the Prognostic test license, maybe change to something like
Prognostic Test Term sheet yet?

Quote:

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BLA
-Clincal BLA - June is best case July Possible
-CMC - August to December. He is going to lean on FDA to move it up so its not december
-FDA will be informed in may of 525 dose as the planned dose

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Our questions Combo/BLA questions listed so far

Anticipation date FDA will give final safety data requirements?
Any response from FDA to our first part of BLA
BLA submission timeline with 525mg vs 700mg?
Did the early discontinues in the placebo arm happen before steady-state? (pvalue for completed between groups <.02)
Why not send BLA Part 3 for FDA to review why we wait on safety data for Part 2?