RE:RE:FDA Breakthrough application is still aliveScienceFirst wrote: Unless FDA decided otherwise.
But clearly, it wouldn't be the decision of TLT not to apply for, for all the many benefits such designation would bring.
But lets assume the worse case scenario, where they would suddenly not apply for Breakthrough designation for whatever reason. We know that data could entice a big pharma to sign a jv much before 2025/2026 in order to make sure it has clinched a deal
But then again, TLT would not have bothered Dr. Kulkarni/Dr.Kamat to shot an interview at the last AUA, if the focus was to take the long road.
Good point ScienceFirst, the AUA was a hit out of the ball park followed by the announcement of the hiring of both a biostatistics & regulatory organization to present a clearer picture of data on patients also out of the ball park. And the grand slam of all is the hiring of Dr. Kaouthar Lbiati.
Well as a kid I played the game Clue and was pretty good at it, as a Clue Master all these recent moves by Theralase says we are a winner.