RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:made the TOP TEN BULLBOARDS AgainAnd there is the FTD they received:
As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system (“TLC-3200”), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes. So maybe it is these "frequent communications with the FDA" that has made her want to change the reporting process, as you say maybe she has applied and was told a little more data is needed. So what's a acouple of weeks or one month?
I realize this is wishful guessing but I think you have to read the tea leaves because those waiting for the actual news take less risk but could miss the boat. Or at least have a much smaller boat.
Legit62 wrote: That was my thought when i researched the BTD process through FDA, doesnt list a day time frame, so my feeling is that she probably has already applied or will so shortly and wants to report this to shareholders at that time, I agree with Skys that she is going to change the reporting process to shareholders, not like in the past. IMO