Sure.The current approved trial design (clinicaltrials.gov) is a...

Sure.

The current approved trial design (clinicaltrials.gov) is a pilot safety study with primary outcome measure safety/tolerability per CTCAE v4.0. From informed consent until 104 weeks post last patient enrolment date.

Secondary outcome measures include;
- local progression free survival within the pancreas throughout enrolment, an average of 12 months
- progression free survival entire body to end of study visit, average of 12 months
- overall survival 104 weeks post ast patient first visit
- body weight
- impaired function
- pain scores

Important notes, trial is standard of care chemo plus Oncosil, non-comparator, everyone gets chemo plus Oncosil. Noone has been allowed to be given Oncosil alone instead of chemo.

The trial is stated on clinical trials.gov to have been designed to meet regulatory requirements. Trial design outcome measures per above align with oncology study requirements to demonstrate safety. Note: to demonstrate efficacy the outcomes measured are pretty similar. The critical differences are introduction of comparators, sample sized increase to 300-400, and 5 year minimum mandatory follow up.

The data submitted is incomplete. There is no mandated 12 month and 2 year minimum required safety and efficacy data for 50 participants.

Clinical data required to demonstrate primary outcome measure of safety measures at 2 years does not exist.
Clinical data required to demonstrate secondary outcome measures of local free survival at 12 months and overall survival at 2 years does not exist.

Re: touted resectability rates, the question remains "so what"? What is the LPF status 12 months later? The entire body PFS status 12 months later? The OS status 2 years later? Are they the same for this patient population as if the tumour was treated with chemo only then resected?

The only clinical experts that matter have concluded insufficient clinical benefit. Huzzah! Oncosil have successfully demonstrated that chemo works.

Why oh why, how oh how, do they believe AIMD & meddev requirements have been met?

Furthermore, what is the longer-term clinical benefit of resecting a chemo plus Oncosil treated tumour compared to a chemo only treated tumour?
Only a longterm RCT investigation will demonstrate statistically relevant LPFS, entire body PFS and OS results.

Note there has been no trial status update on clinicaltrials.gov since July 18 so I can't be certain how many weeks worth of how many patients data was presented. But it was not what the trial design required.

Anyway, food for thought. Check out clinicaltrials.gov. There's some good information there.

Best of luck to you.