The GREENFUND - we're buying the dip, big time, and here's why., page-55

Mmm … its complicated; because it can be both. A trial pharmacist can “manufacture” an investigational product by compounding; mixing up a brew.

But more commonplace and in a trial like the one here - yes “manufacture” would encompass the dolling of individual portions and the labelling. The site takes over with respect to stock management, storage, preparation and dispensing.

But look take a step back here.

There is always 1% of truth to these company dog ate my homework type explanations to failed trial results. So sure there might have been minor variation in vehicle quality but nothing to the extent that explains that placebo response.

But lets say it was true. What would happen. Well basically it’s a runway train scenario.

The PIs have no choice but to notify their IRB of this protocol violation (which this is) that has essentially negated the scientific value of the US component of this trial. Many US participants have essentially wasted their time taking part in this trial.

The IRB has no choice but to inform the FDA. The FDA would inspect those manufacturing sites. Given the difficulty BOT seem to be having in getting on top of what has happened the record keeping quality control must be terrible. The FDA would close them down.

Why this big drama – because of the safety risk.

A child experiences an unusual adverse health event. The mother takes him to ED. She informs the clinician the child is on a clinical trial for a new acne treatment. She doesn’t know what it is exactly or whether the child is in the placebo or active arm.

The treating clinician will ring the trial pharmacist / Study Coordinator who will break the blind to inform the clinician what treatment the child is receiving. Good news the Study Coordinator says … it’s the placebo. A vehicle … completely harmless. Thanks says the treating doctor we can rule that out. But it turns out the placebo was really an active. What a potential disaster.

This just can’t be allowed to happen.

So have the PIs / BOT informed the US IRBs of this stuff-up? Has the FDA been notified? If not - why not? If this manufacturing stuff-up is true and the PIs and BOT haven’t notified the IRB / FDA they would be in breach of a dozen US regulatory laws.

They haven’t because the manufacturing variation (or problems) is in reality inconsequential. It is only in BOTs head that this caused the trial to fail. No-one else thinks this because if they did then they would have reported it because they don’t want to go to jail.