Jesster,
I'm no expert on what they can or can't do, I'm saying what I'm saying because of observing what other companies do, and whether laws apply, or just fear of the regulators, most companies don't like to do anything that the regulators might consider hype.
I frankly hate what the regulators have done. Annual Reports used to be something like a magazine featuring all the company was doing and planning to do, it was enjoyable to look through. Now much of what's in the report involves the risk of investing and all that can go wrong. I believe most investors skip these sections for the most part, but they must be included.
Yesterday I was talking with a retired Dr. friend about all the cautions that must be included in commercials for virtually all drugs. His point was that in a trial, if a patient gets a headache, the only way not to say it may be a side effect of taking the drug is to run perhaps millions of dollars worth of trials to prove it doesn't cause headaches. It's easier and cheaper to just say it may be a side effect. I would much prefer a simple statement that Drs. prescribing a drug should review side effects, and not list everything that was seen during a trial, but the regulators don't see it as I do.
The FDA ought to be in the business of finding the products that benefit patients with deadly and debilitating diseases, once they see it, at minimum an EUA should permit it's purchase while further data is developed to warrant full approval. If that were the case with DCVax-L I believe at the time they halted the trial they knew enough to issue that EUA. At a minimum the FDA, or other regulators, should review what's happening in a trial after each 3, 4, or 5 year increment to determine if enough is known to issue an EUA. Liability should be limited when a product is under an EUA as both Dr. and patient are taking added risk to potentially gain an added reward.
No trial should be permitted to exceed a decade in length without some sort of regulatory review that could result in at least an EUA, and perhaps a full approval based on the benefits being seen. It shouldn't take a million or more pages to see what's right in front of your eyes if you really look at how patients in a trial are doing.
Gary
Bullish
