At 2Q cc, they mentioned end-of-year (mid to end 4Q) as time to post P2b meeting, and 2Q/19 for P3 start. Obviously, this time-frame they can not satisfy. Again they mentioned exposure-dose/regiment human PK trial/study ongoing (I doubt that this is pure math from completed P1 PK trials), but I can find (about) any info on net.
So, I will take as granted that FDA meeting will be in 1Q/19...and go from there.
Than again, "The third batch of the Phase III active pharmaceutical ingredient, API, is due to be completed during Q4 2018 and the rest of the manufacturing compliances are ongoing.", with plan to complete 600 kg total P3 Aramchol, is more positive than any 1Q delay in P3 start (IF there is no further delay). From API to formulation (tablets/capsule) it is another 2-3 months,...so.....with CMC package in place and with solid P2b data (IF all is true)...there should not be any further delay.
Anyway, I am just looking for trading opportunity, with limited downside (IF possible in current market). |
