I would think that Medicare, Medicaid, and the insurance companies would make or break this cologuard rather than any advisory committee. I don't see why those folks would want to spend thousands of dollars when there is a cheaper 'Alternate" method to accomplish the same purpose.
I was under the impression that congress had given the FDA authority to approve a drug if the drug
was beneficial and did no harm for diseases that have no current healing effects. Why wouldn't the FDA just go ahead an approve SRPT's drug now based on the data we heard today? I see no reason for the FDA to allow these boys to continue to suffer like they are today. If we don't hear from the FDA by the end of next week, call your congressmen.
Since effects are mild so why would the FDA not approve this pill? It's ok to give teens Marijuana that has never been tested but you can't give a woman a pill that she really doesn't have to have (they can live without it). This is not a life and death decision. Make it available and if the woman can't tolerate it, they can just not take it. If it helps others great. It not like if women start running down the street nake and asking guys to have sex with them that the FDA can't recall this drug.
Have you read his bio? A poor troubled black kid raised by a single mother and went to Yale on a government scholarship. I think we have done this one before and it didn't turn out to well.
Let's see. A company gets FDA approval for their drug and the EU approves the drug to be sold in Europe but we are expected to believe that the drug is no good and that no one will buy it. Hard for me to follow. Shorts are trying to get out cheap in my opinion. Keep selling dummies.
Does anyone think that there maybe a market for personal body cameras? It's kind of like putting a camera in your home to secure your belongs. If you have on a body camera and someone tries to rob you just tell them that they have been recorded and that they need to think about what they are doing. If you were robbing someone and you knew you were on camera, would you harm that person knowing that the cops have a video of you? Put a body camera on your children to help keep them safe might be a big selling point. I believe that obama might even give them to low income folks.
Just because a trial is closed early doesn't mean it's bad news. If the data is good enough and end point has been met, many trials will end early. The only news I can see is that the trail was stopped early and the data is being reviewed. Any chance we have good news?