Dan88 Friday, 03/11/16 01:44:20 PM
of 56715 Go
My gut feeling about the current temporary halt and it's a common sense too, though mine:
NWBO initiated the halt while submitting certain trial information seeking for 1) approval for a specific group of patients, the m-subtype patients based on overwhelmingly good and significantly rich data showing DCVax-L can greatly benefit this specific type of patients; or 2) at least add specific clauses into the existing protocol so that when IA analyses or final analysis is conducted this specific group of patients will be specifically analyzed and treated for approval.
While the regulatory process (negotiation, review, etc.) is still going on the trial has gradually reached its specified endpoints: interims. Since the company is not seeking fundamentally change the trial and its goal as some naysayer have argued, the trial will at least be analyzed according to the existing protocol (or part of the protocol if the company is successful to incorporate the aforementioned request into the existing protocol).
Because of this, I believe FDA is still weighing on whether the data is adequate for the request, or whether it should take a look when a prespecified events are reached on the m-subtype of patients and/or the overall patient population.
It is unwise and unethical and dumb for not separating this particular group from the whole in assessing approval as personalized treatment truly gets specific and personal, which is a definite development trend in cancer treatment developments around the world.
Below is a link of LL's 29 Feb 2016 youtube presentation (upload date of course) which I believe is most recent talk she has given and one definitely after the one withdrew some time ago:
David Geffen School of Medicine at UCLA, 29 Feb 2016.