RE:RE:RE:RE:RE:RE:RE:RE:RE:Is this the year?Yes Yajne it's funny how often, when people stay on topic, that the old news releases get quoted because we either missed something or just forgot.
In your quote it shows just how involved the FDA already were. At the AGM I attended right after the disastorous financing I think they met with the FDA that very day. And in this release it says "which the FDA has previously defined to the company" so Shawn continues to mention 25 patients knowing full well what they are looking for.
So I believe when number 25 is treated anything can happen but everyone's circumstance is different. Someone with 20K shares probably wants $20+ so they are more anxious timewise but someone with 500K+ will accept a move to $3 - $4 in the short term to take some profit and let the balance ride.
The bottom line for me is I think everyone will be happy in weeks or a few short months and not years.
Yajne wrote: Good points StevenB and Oilminer...I also wonder if their access to the FDA gained through the FTD could play a strong role here in the timing of FDA review of StudyII leading to BTD and AA. From the Nov 23, 2020 NR:
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. StevenBirch wrote: They did stop Phase I early and yes it was to study primarily for safety but I think it shows that there is wiggle room for the FDA to decide based on the strength of the results.
As always we remain optimistic.
Oilminerdeluxe wrote: Perhaps depending on just how strong the numbers are, that might speed things up? Just speculation. Have a nice weekend everybody