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Posted On: 08/26/2020 12:40:57 AM
Post# of 148903
Cassandra,
The minute that the FDA approves Leron* doctors will be free to use it any way they want. It is call "off-label" and it is perfectly legal and acceptable. As an example, one of the drugs injected into the eye has been used "off-label" for decades. There is plenty of research to support it. Lot's of randomized trials, but nothing that the FDA required. The research was routine and orderly.
The FDA knows all of this of course and that is one reason they are so careful with approvals.
Aids treatment will be the approved application. That's why FDA is going out of its way to get as much as they reasonably can without killing too many patients that need it approved. They already know that the drug works, but they only have one shot to get the side effects spectrum nailed down. The statistics will be used forever... as close to perfect as possible is really important.
Any time now. Hang in there.
The minute that the FDA approves Leron* doctors will be free to use it any way they want. It is call "off-label" and it is perfectly legal and acceptable. As an example, one of the drugs injected into the eye has been used "off-label" for decades. There is plenty of research to support it. Lot's of randomized trials, but nothing that the FDA required. The research was routine and orderly.
The FDA knows all of this of course and that is one reason they are so careful with approvals.
Aids treatment will be the approved application. That's why FDA is going out of its way to get as much as they reasonably can without killing too many patients that need it approved. They already know that the drug works, but they only have one shot to get the side effects spectrum nailed down. The statistics will be used forever... as close to perfect as possible is really important.
Any time now. Hang in there.
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