Where others have failed will Atl1102 succeed ?, page-43

I am expecting something very clean from the FDA. Unlike the back and forth back in 2017 for MS, this time I’m hoping (fingers crossed) that the FDA say they will waive the 9 month regulatory Tox timeframe and allow ANP to move forward after the 6 month safety data.

“All looks good guys, go for your life!”.

If that is to occur, i expect some other type of partnership / collaboration news with either rare disease indications or other major disease indications.

Also.. and this is a low probability, but still a possibility, that there is just 1 trial combining both the EMA and FDA trial.

@monti901 if there are any games, its Pfizer’s doing. Scott Gottleib, who is on the PFE board, is the former head of the FDA.

Interestingly, ANP had its meeting on April 19. On May 4th, Pfizer announced they were delaying the commencement of dosing for their P3 DMD gene therapy program stating questions from the FDA. Coincidence? It’s probably nothing but the FDA is an arm of the US govt and PFE is one of the largest and most influential companies in the US. The lines of communication from the top of Pfizer to the top of the FDA would be very open.

Either way, Europe is moving ahead and ANP is dirt cheap just on that basis.

Fingers crossed. Lets see.