RE:RE:Plan to resubmit early Q1 to FDA From what I understand, once pre BTD is submitted, they will know within days if all is OK to submit full BTD. Then BTD takes 60 days, so if they end up submitting pre BTD early Q2 hopefully, then it's possible to get BTD submitted also early Q2 and get answer end of Q2 or early Q3 ( June -July). All IMHO and a good question to ask.
judgesmails wrote: Agreed. Plan from before Christmas was pre BDT submission in early Q1 and actual BTD later in Q1.
Then January update said pre BTD in Q1 sometime and BTD in Q2.
Now it is pre BTD in Q2 and BTD submission later. Hopefully later in Q2...but not necessarily.
"The Company plans to resubmit the pre-BTD submission to the FDA in 2Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company will compile a BTD submission for review by the FDA in support of the grant of a BTD approval."
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It would be nice to understand something about the delays