According to a typical charter of IDMC (see my previous FDA link):
GALE, IDMC, Mittendorf (they) most likely participated in all of the open meetings. The biostatistician overlooked trial procedures/randomization.
They new they had to accrue an additional 45 patients to keep statistical power.
They were able to extrapolate recurrence timelines.
The chair of IDMC had a conversation with Mittendorf and or Schwartz prior to written recommendation.
It seems to me that the results are skewed and likely significant. It seems to me that Mittendorf was able to convince the chairman and biostatistician that something went wrong. In return, instead of suspending trial, GALE agreed to stop it as if there was a systemic reversal, data compelling to halt and submit. That's the chance they are taking.
Longs, one SUPER KEY trigger point this week. Long time waiting.
Looked at phase I, II and phase III data: this part of the dossier ready to submit.
Phase II data, sub analyses with dose/booster and response rate=ready to submit.
All biomarkers studies published: solid irrefutable data ready to submit file.
Mechanism of action of neuvax: solid and irrefutable data ready to submit.
Manufacturing data: ready to submit.
Phase III, interim: efficacy for the first 70 events ready to submit. Will the score be 10/60 events in favor of Neuvax, triggering halt? We are close to finding out.
Huge....Rolling Review........which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
Tick tock tick tock. Not too many days left before something huge is announced....tick tock
This law firm copies and pastes this type of investigation at least twice a month on a whole bunch of different companies. Is this really the rule of law? This is more of a manipulation tactic than anything else. They are not representing me.
Can we stick to facts. To scientific facts. To GALE's potential going forward? Oooof....I need a break.
The other point in the letter is the urgency to conclude their investigation. Why the urgency when the trial is stopped?
Oncology (Williston Park). 2016 May;30(5). pii: 217054.
Excellent review. Scientific rational behind each and every step taken thus far. Scientific proof behind mechanism of action. Read this. Not the dummies on this board.
Must add, they will look at blood work/surrogate markers/ antibody to help confirm randomization. Un blinding happening as we speak......
Indeed. I strongly believe they had no choice but to stop for safety (and liability) reason. BUT, the committee had to be convinced, the biostatistician had to agree or even suggest. Something was off. They will likely have to review randomization of the 750 patients. Maybe they had to get the FDA involved? Turn of events.
The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors
Search for this.
Section 4 and 5 of interest.
AGAIN! None of us here predicted this. These guys are getting things done. Really good news today.
Exciting news to come. I think they are probably awaiting an FDA committment prior to announcing the interim results. Stay tuned.