FDA approved without Randomized Controlled Trial, page-2

Totally agree Trump and desperation drove this remarkable FDA decision. There will be a lot of objection from medical and trial experts. It appears based on observation of responses to these drugs in case studies in China and France, not on randomized, controlled trials. From the article linked by @The Yankee"limited in vitro and anecdotal clinical data in case series,"

And the Chinese "study" did not even confirm benefit.

At least the FDA has also "encouraged" a proper controlled trial, as quoted in the article.
Anyway, we all hope it works and doesn't come at an unacceptable cost in side-effects. The whole world needs it and now.

The hope of using hydroxychloroquine sulfate and chloroquine phosphate is to treat patients who have acquired the viral infection or maybe prevent it. They might prevent progress to ARDS where successful but if a patient does get ARDS these drugs won't prevent death. They don't treat ARDS.

There will still be untold numbers of seriously ill patients who couldn't access those drugs, or couldn't tolerate them or in whom they just did not work. Many of these will progress to ARDS and will die unless that condition becomes treatable.

Reports state that there are numerous trials around the world, seeking ARDS treatment. MSB and ATHX already have product. We know more about MSB's Ryoncil.

- We know it is safe. Been tested many years and in Japanese clinics for 3 years.
- We know it works for its Japanese approved indication, aGvHD.
- We know it has succeeded in an FDA approved phase 3 trial.
- We expect FDA acceptance of a BLA for aGvHD use in USA any day now.
- We know MSB can manufacture it in industrial quantities right now.
- A post hoc analysis of an early trial indicated Ryoncil has a mode of action that counters the cytokine storm that kills SARS and ARDS patients. It worked in patients with serious lung conditions
- China reported a small study that showed salvation of ARDS patients treated by MSCs

Nothing new there but the revision helps when we now try to imagine why is happening in MSB departments around the clock and around the world.

I envision MSB experts at planning FDA acceptable trials rapidly defining the trial conditions; they've done it sufficient times before.
I expect that an FDA that has accepted the Trump driven experiment with malaria drugs would have no problem passing the work of MSB experts whose professionalism they are very familiar with.

I confidently expect that hospitals desperately praying to save ARDS lives will clamour for a possible treatment from the world's leading MSC company with its high repute and repeated approvals from USA KOLs
in cardiology, haematology and spine surgery. No need to convince them to try.

As far as the trial itself goes, we can only guess. But we sure are not expecting many months duration, let alone the usual years. If this stuff works (or not) the survival and hospital discharge rates will reveal it in a week or so after first dosing. These people are at death's door. It won't take long (days) before there is or is not a clear distinction between the active and control groups. Possibly within a week of first dosing.

My guess is results before end of April, possibly even by Easter. But that guess depends on when the treatment starts. For sure, it will be just as soon as the paperwork is approved because MSB is ready to administer right now. And you can bet everything you own that MSB is doing this as fast as is humanly possible.