Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-123

Itsagas: I don’t know what all the fuss is about..
Fda is in communication with Anp re Fast Track.
In order for FAST Track to be approved Anp had to submit a 9 month trial study on monkeys to prove safety and tolerability and a 2B/3 study on DMD people in the US using a higher dose and a longer 12 month term.

In order for a higher dose study the existing partial block for 25 mg per week had to be lifted in a formal way so that Atl1102 can be set up for registration type studies in the US.

FDA didn’t reject F.T.
It’s a work in progress until the FDA and Anp get it right.
CG signed off on the announcement saying exactly that..
Who are we to criticise the announcement.. have we more experience than CG our new Chair ?
Stop being kids and accept that Anp and 99% of Biotechs are volatile because nothing goes in a straight line...the losers are the people who SOLD.. j$$$$$