Biotech Values

[dangerM]

ONCS

See here https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146546013

I had to get the paper on Imlytic first (it's really impressive in the real world setting although the majority did not try immunotherapy first and as such would not have been allowed to take part in Oncosec's trial).

So, well, 23.8% ORR is less than the previously assumed 30% ORR in the design of the trial (then Simon's 2-stage). But since IMHO there are clinically relevant responses I'd say the trial (with a reduced assumption of 20% ORR) still has the chance of success to become the basis for an accelerated approval.

The risks now are time and money, but IMHO no longer effectiveness. Time, since for an accelerated approval the FDA sets the bar at the current landscape at the time for an approval* (and enrolling and treating the full N = 100 takes a bit time, now it's N = 33 of which N = 21 had been evaluated). Money, well, it's a biotech.

dM


* this is why I really had to look into the paper on real world Imlytic use first