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Denisk

01/29/26 2:13 PM

#2532 RE: rosemountbomber #2530

I just sent a email to KGarner asking about that. Let's see if they respond.
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Denisk

01/30/26 6:17 PM

#2564 RE: rosemountbomber #2530

Hello RMB:

Just want you to know that I got a reply today from Kgardner re the TDAPA. Here is what he sent me via email:
Hi Denis,
A company cannot apply for TDAPA until the drug is approved.
"PDUFA date is June 29. The company will quickly apply for TDAPA soon thereafter and is confident they will be in good shape for TDAPA designation on January 1, 2027.
Best regards,"
So apprently they are very much aware of the timing issue .