Theralase Technologies Inc. V.TLT

Thanks Wildbird

[CancerSlayer]

The FDA's recent approval history for BCG-unresponsive NMIBC (i.e. Keytruda, Adstiladrin...) indicates that the goalpost/threshold for approval has been lowered in terms of CR/DRR.  The goalpost has also been moved closer when considering the fact that more options are needed...as expressed by the FDA & regardless of who wins the CR battle.

Re: the Adstiladrin approval, the FDA states in their Summary Basis for Regulatory Action, dated Dec. 16, 2022:

"The basis of FDA's conclusion of substantial evidence of effectiveness comes from a single adequate and well controlled trial with highly persuasive results on the benefit of CR rates, along with duration of response, supported by the initial clinical investigation, clinical pharmacology, and preclinical studies. Therefore, the evidence supports regular approval for ADSTILADRIN."

If a 23% 12 month CR rate is "highly persuasive" per the FDA, our numbers should really be a slam dunk...imo.

[Oilminerdeluxe]

It's been a year since the last pre-BTD was sent in if memory recalls. Hope the FDA has not found some other thing they want to be included this time around. If TLT has got everything that was asked of them, then actual BTD feels like a certainty. What a world of possibilities that can open up after that. 

[Legit62]

Hoping to hear something by Monday ,end of3rd qtr