RE:This is what I was hoping forSo we've known for a while that TLT's results are superior to it's competitors, even ones that have been FDA approved, thanks to our own experts here and now it seems the FDA wants the data presented in a format that the others have used and makes it more obvious to everyone else...before granting BTD to TLT. That seems reasonable.
Kayz88 wrote: The company met with the FDA in mid-October and the FDA suggested a different format to present the clinical data to better align with clinical data supplied by other companies for this disease. Theralase has now recompiled its clinical data and resubmitted to the FDA at the beginning of December. We expect to schedule a meeting with the FDA in late December, early January to review the new format and hope to gain FDA approval to submit a BTD application in late December, early January with a hope to receive BTD approval before the end of first quarter 2025.