Multiple thoughts. thanks again noteable for exaplsing the variou approval pathways.
Ultimately, the approval for Pelareorep be marketed is the only goal.
onc mangemet did not on their own randomly decide to bring about Bracelrt, Aware-1, or Gobblet.
All were initiated at request if FDA & the various colaborators. Pfizer, Roche, Incyte.
The PanCan organization etc etc.
There are many outside eyes watching & validating the various trials & outcomes.
One reason Noteable needs to repeat things as a few side show band of bashers, either collectively have an I.Q. That of a baked potato, or just continue to throw out random distractions.
Granted there are legitimate concerns. Saying phase 3 could have been started 3 years ago, ..or when ever?
it was at the time when they were granted FDA fast track for MBc, that things were looking full speed ahead.
it was clearly discussed at the time to de- risk the trials , the FDA advised a window of opportunity study to identify pre- full- on treatment, a biomarker.
Aware-1, & subsequent trials have indntified two.
That being after 2 weeks , a blood draw will indicate if the patient can respond or not to Pela.
That very science, is the partial request of the FDA type C meeting.
in plain language, they can reduce patient numbers, (/saves $$), and reduce overall length if trail ( saves $$) and ..the derisking part.
Simple, yet very significant.
pre- screening non- responders, can statistically increase the efficacy Benefits.
hence..de- risking the phase 3 trial.
THAT, came from advice from FDA.
build the best trial possible, with the best pre- trial screening. Thereby reducing the likelihood of trial failure.
regretably has taken more time.
Now?
Axe soon as FDA responds, the MBc phase 3 trial will be in concept ready to roll.
next step?
who will be the partner to move that forward.
if I was one of those with a few billion $ at risk. I'd wait until the FDA responded.
Having as much info as reasonably possible.
That is good business & good science.
The Gobblet , pancreatic , anal etc was an added bonus in the wait.
I respect , Noteable for his tenacity.
memem keeps asking about a date. Like the old records that kept skipping.
The date will be when we see a N.R. With details.
Not far away.