RE:Congrats on FDA Approval of INDmade2last wrote: Hi All;
Congrats Theralase on receiving FDA Approval of the long awaited IND and P2 to follow in the USA.
Let's focus on Theralase, and leave ALL non pertinent political musings for another venue.
Thanks;
made2last
yes, congrats Theralase. I think the FDA heard all the moaning and groaning on this board over the weekend about how old we are all getting LOL
and yes lets keep politics off here going forward and I'll take people off ignore.
One part of the announcement today to reiterate, most important :
Shawn Shirazi went on to say, "In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval ("FTA") post receipt of the FDA IND authorization, based on the clinical study data collected to date. It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation ("BTD") and / or Accelerated Approval ("AA"), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated."
Coop