I believe if the regulators would pay attention to the Hippocratic Oath they would approve drugs, like those Anavex has in trial, for broad use, but insist on conformational trials to maintain them on the market. I believe it's clear that patients either see benefit, or are no worse, in essentially all indications the drugs have been tried on. If something better than that were available, it would be approved, but it's not.
To me, a conditional approval is far superior to taking years, perhaps even a decade and hundreds of millions to run further trials while millions go untreated. With the conditional approval, I would have every patient have treatment results reported in a Phase 4 and that too could be the basis for making the conditional approval into a full approval.
I hate to continue saying it, but I believe the regulators should be far more pro-active. They should be looking into trials while they're underway and if they clearly see benefits, do conditional approvals immediately. In most cases this probably would cut off perhaps 5 years and a great deal of the cost of clinical trials and have the potential of saving many lives. I believe that benefits seen in most Phase 2 trials should be sufficient to see such benefits, and a million pages or more to prove it is ridiculous if the regulators could pro-actively speak with clinicians, patients, the DSMB, etc. and make a decision for themselves. If they don't wish to call them Conditional Approvals, call them EUA's. the point is not taking decades to take a product from preclinical development to availability to the patient. They did it for Covid 19, for the person with other deadly diseases, like pancreatic cancer, it's just as important to make miraculous products available in months, not decades.
Gary
Bullish
