[dirk digler]

Originally Posted by DJ's left nut

I wonder if that speaks primarily to wholesale implementation.

Hamas mentioned certain demographics don't respond well or suffer adverse side effects due to these cocktails (IIRC) and that would seem to suggest that maybe they're going to have to firm up data before they simply take their hands off the wheel and allow it to be used across the board.

Especially if, as I believe Hamas suggested, there are concerns over growing resistance and thus long-term declines in efficacy.

But it would seem that they could allow targeted applications fairly quickly. And public pressure will mount exponentially to do exactly that.

Originally Posted by BleedingRed

Didn't this administration sign a bill for this type of thing "Right to Try". maybe provisions of that law could be used to go around the FDA

The side effects are seizures, nausea, vomiting, deafness, vision changes and low blood pressure.


I think they approved it for compassion cases which we all know what that means.

FDA Commissioner Stephen Hahn carefully tempered the President's remarks regarding his team's work to develop treatments for coronavirus.

"The FDA is committed to continuing to provide regulatory flexibility and guidance, but let me make one thing clear: the FDA's responsibility to the American people is to ensure that products are safe and effective," he said.

He said the FDA is expanding its work regarding potential therapeutic options.

"We need to make sure that this sea of new treatments -- we'll get the right drug to the right patient at the right dosage at the right time," he said, explaining that the right drug may be available but it may not be in the right dosage, "and that may do more harm than good."

Part of that, Hahn said, is exploring drugs that are "already approved for other indications," noting the President's remarks on chloroquine.

"That's a drug that the President has directed us to take a closer look at as to whether an expanded use approach to that could be done and to actually see if that benefits patients. And again, we want to do that in the setting of a clinical trial, a large, pragmatic clinical trial to actually gather that information," he said.

He also explained the process of convalescent plasma, which has to do with isolating blood from those who have survived the coronavirus and have the right immunoglobulins. A concentration of that could treat people infected with the virus.

As for a timeline, Hahn said, "over the next couple of weeks, we'll have more information that we're really pushing hard to try to accelerate... and that will be a bridge to other therapies that will take us three to six months to develop. And this is a continuous process -- there is no beginning and end."