I believe that in reality if the company had unlimited funding they would have many more trials against many different targeted diseases. They don't have that unlimited funding, so they made choices that they believed could get them approvals in a reasonable amount of time and cost. Of course that was before Covid-19.
Covid-19 provides an opportunity that I've never seen before. I have no doubt that if our Phase 2 Trial is clearly saving lives, it might not even have to reach it's conclusion before the drug is made available for sale. You'll not I'm not saying they can provide TLD, prepare a BLA which might take 6 months, then have the FDA take 6 months to review it, No all that can be eliminated, the FDA and regulators all over the world will give the okay to treat with our drug.
I believe it will be up to those running the trial to consider stopping it early, though I believe it's to complete in a few short months. If the clinician clearly see some people getting better, some not, they could suggest unblinding early, and if those getting worse were all on the placebo, they could be given the drug.
If I were running the FDA, all in the trial would be getting the drug, I don't know how a placebo that's injected into an unconscious patient can possibly create a placebo effect. Last I read roughly 80% of those put on ventilators don't survive, why not let all not getting the drug be your control, and all those in the trial the subject of the trial. Yes, that lets the clinician know, why shouldn't the clinician be trusted to do it correctly. There really are only three possible outcomes after 28 days on treatment, two of them are very observable, one is you're better, and off the ventilator, the second is you're dead, that outcome can't be denied. The third is that you're still on the ventilator after 28 days, perhaps another dose could be considered, or the patient just stays on the ventilator, eventually they'll join one of the two groups.
I would suspect that by October or November at the latest we'll know, and if the results are positive, they'll be an approval to use it. It may not be like a normal drug approval, but PLX-PAD will be available, and hopefully the company will have sufficient drug to reach all on ventilator, and those nearly on ventilators. Ultimately it will be given prior to hospitalization, and hopefully most will never need to be hospitalized.
Gary
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