The only way people are counted in a trial is if they're enrolled in the trial and on the trial protocol. In some cases, patients in say a Phase 2 Trial will be counted in a Phase 3 if the protocol is identical. Essentially it's allowing the Phase 2 to transition to a Phase 3. In some cases approval can come out of a Phase 2 Trial without expansion if the data is sufficient to justify it. I believe PSTI is calling the trial we'll start as a Phase 2, but it certainly could lead to approval if we continue to see the sort of results we've heard about from the first 7 to receive the drug.
I would suspect that if our Phase 2 was a 300 person trial, and if we were 100 patients into the trial, and let's say over 80 of those people had already come off ventilators, it would be possible to stop the trial early and gain almost immediate approval. The thing is, it wouldn't be the company suggesting it, it would be the independent people monitoring the trial who'd report what they're seeing to the regulators.
It's unusual for the regulators to stop trials very early, but we're in very unusual time, and I believe that benefits under clinical conditions could get the attention of the regulators very quickly if they're as solid as I believe they could be.
Back in 2001 I first heard of Gleevec when it was approved very early in a Phase 3 Trial. I viewed it as a great drug for the drugmaker, as it held leukemia in remission as long as people stayed on it. Little did I know that I'd be taking it many years later. Even though I've had stem cells, I remain on a chemo, the third generation of Gleevec, because if I didn't the odds of coming out of remission are greater. The odds are on my side regardless, but better if I stay on the drug.
I don't believe that approval can come in under a few months time, but if we get started this month, if great results are seen by June or July, I believe our drug could be available by Fall when the experts believe both flu and coronavirus will be hitting us again. The good news may be, testing wouldn't even be necessary, if someone has pneumonia, regardless of the cause, PLX-PAD will benefit nearly every patient. If we're smart, patients will be dosed as soon as pneumonia is detected, that will keep most of them out of the hospital completely. Such treatment will certainly be expensive up front, but it will save far more as whether it's flu or coronavirus, tens to hundreds of thousands of people die annually, and for many death comes after weeks or even months of time in the hospital.
Of course I'd advise anyone with pneumonia to attempt to get PLX-PAD either by getting into a trial, or on compassionate use, I certainly would if it happened to me.
Gary
