Trump: We’re “slashing all of the red tape to get very important things to the market... medical.” Notes #COVID19 vaccine trial started this week, launched in record time. Pursuing antiviral therapies - “that’s the purpose of being up here today.”
Trump: “Doing great with the vaccines, but still a long process but therapies are things we can move on much faster, potentially. ... Looking at things to make people better or at the very earlier stages they wouldn’t even know they had it.” #COVID19
Trump: FDA Commissioner Stephen Hahn “is fantastic. He’s been working 24 hours a day, worked like probably as hard or harder than anybody in the group other than maybe Mike Pence, or me.” #COVID19
Trump: “I’ve directed the FDA to eliminate outdated rules and bureaucracy so this work can proceed rapidly, quickly - I mean, fast. We have to remove every barrier.” #COVID19
Trump: “We think we have some good answers. We’ll find out very very soon. Clinical trials are already underway for many new therapies. We’re working on scaling these to allow many more Americans to access many more drugs that have shown really good promise.” #COVID19
Trump: If treatments known to be safe in Europe, Japan, other nations, we’ll use that information to protect the health and safety of the American people. #COVID19
Trump: Chloroquine - malaria drug, around for a long time, very powerful - but nice part is it’s been around for a long time. So we know if things don’t go as planned it’s not going to kill anybody. When you go with a brand new drug you don’t know that’s going to happen. #COVID19
Trump: Chloroquine has shown very encouraging early results. We’re going to be able to make that drug available almost immediately. FDA has gone through approval process, it’s been approved - took it down from many, many months to immediate. #COVID19
Trump: Chloroquine is going to be available by prescription. There’s tremendous promise based on the result and other tests. Normally the FDA would take a long time to approve something like that. Now approved by prescription. Individual states will handle it. #COVID19
Trump: There are promising therapies produced by Gilead, remdesivir. That drug also has been approved or very close to approved in that case by the FDA. #COVID19
Trump: So you have remdesivir, chloroquine and hyroxychloroquine. Those are out now, essentially approved for prescribed use. I think it could be a gamechanger, and maybe not. Very powerful, they're very powerful. #COVID19 $GILD
FDA Commissioner Stephen Hahn: It's important not to provide false hope, but to provide hope. As a doctor, that's how I come to this. #COVID19
Hahn: FDA's responsibility to the American people is to ensure that products are safe and effective, and we are continuing to do that. Our folks... are working day and night to do this. #COVID19
Hahn: Since early January, FDA started working in collaboration with CDC. One thing I know about this great country of ours: we have unbelievable innovators. These great American innovators... they have engaged us about the best possible treatment options. #COVID19
Hahn: We need to make sure in the sea of new treatments we'll get the right drug to the right patients at the right dosage at the right time. #COVID19
Hahn: In the short-term, we're looking at drugs that are already approved for other indications. As an example - chloroquine, anti-malarial. It's already approved for the treatment of malaria as well as arthritis condition. President has directed us to take a closer look #COVID19
Hahn: We want to do this in a large clinical trial to get at the questions that need to be asked an answered. Another area: convalescent plasma. #COVID19
Hahn: Convalescent plasma is a bridge to other therapies that could take 3-6 months to develop. #COVID19
Dr Deborah Birx: "Our test positive rates are into the 10-11% range." That means 90% of illness out there caused by other things. #COVID19
Hahn asked when remdesivir will be available on market: "I'm prohibited by law from disclosing confidential commercial information," but we're working very closely with the company and should get information very soon #COVID19 $GILD
Hahn: Remdesivir is currently in clinical trials here and around the world. We've also made it available through compassionate use. Allows us to collect the data, so we can understand the data and science to make appropriate decisions about safety and effectiveness #COVID19 $GILD
Hahn: Remdesivir is going through the normal process. #COVID19 $GILD
Hahn: This is an unprecedented time. Notes FDA's "sacred trust" with American people about safety & efficacy, while also trying to expand use of promising therapies #COVID19
Trump: If chloroquine or hydroxychloroquine works, or anything else they're looking at, your numbers are going to come down very rapidly. But there's a very real chance they might work. #COVID19
Hahn: I don't want to speculate about a timeline at this point (about when remdesivir, chloroquine will be broadly available for use) #COVID19
Hahn: We're working hard to fast-track vaccines as much as possible to see if timelines can be sped up
Note: Fauci said last week anyone going faster than 12-18 months to broad use of vaccine would be cutting corners
#COVID19
Note: Fauci said last week anyone going faster than 12-18 months to broad use of vaccine would be cutting corners
#COVID19
