What that means is that they dont plan on applying for US approval for many more years. The fact that they are considering compassionate use program in the US indicates that BLA wont be submitted for many years.
Why would they even talk about US compassionate use program.......Just Submit to the FDA already. Oh But they they can't and they know it.
The unbelievable gaslighting in the 10Q.....
7 years since the trial ended and they are dangling setting up a compassionate use program in the Us...gtfooh with that BS. I feel sorry for anyone that actually is happy to hear that.
Right. Truth is Regulators hate Wild West Specials programs while running clinical trials. That’s why you see it so rarely done. I have my doubts that MHRA sees the Specials data as anything more than another red flag. Add to it LP refuses to share the Specials findings with the public even though many must have access to the outcomes.