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Posted On: 11/14/2021 10:44:37 AM
Post# of 154865
Respert wrote:
That's exactly why I'm very hopeful about the BTD application.
Let's say conspiracy wingnuts like myself are right, and the FDA is purposefully keeping a lid on this drug. Now maybe they'd like to crush the company, but maybe all they need to do is protect the billions of dollars in revenue BP gets from lesser drugs like Keytruda. Giving Leron a BTD designation doesn't really HARM Big Pharma; it doesn't take a nickel away from BP's revenues. And it does give the FDA accountability: Hey, maybe we sank their CD12 trial and put out a completely uncalled-for public letter wrongfully blasting the drug, but we gave it a BTD, didn't we? They can always haul out the old RTF letter trick. Hell, they can always reject the BLA, since they do it in about half the cases of drugs that get BTDs. Giving Leron a BTD doesn't mean we're in. But it would REALLY reverse the share-price direction. So it's a good middle solution, right, FDA?
Quote:
...I’m seeing posts about BTD of LL as if it’s an approval.
It’s not.
It’s exactly what the name suggests, a designation. With the “approval” of that designation we would see many benefits.... But ultimately we still will need to run as many trials as necessary and jump through an annoying large amount of hoops...
That's exactly why I'm very hopeful about the BTD application.
Let's say conspiracy wingnuts like myself are right, and the FDA is purposefully keeping a lid on this drug. Now maybe they'd like to crush the company, but maybe all they need to do is protect the billions of dollars in revenue BP gets from lesser drugs like Keytruda. Giving Leron a BTD designation doesn't really HARM Big Pharma; it doesn't take a nickel away from BP's revenues. And it does give the FDA accountability: Hey, maybe we sank their CD12 trial and put out a completely uncalled-for public letter wrongfully blasting the drug, but we gave it a BTD, didn't we? They can always haul out the old RTF letter trick. Hell, they can always reject the BLA, since they do it in about half the cases of drugs that get BTDs. Giving Leron a BTD doesn't mean we're in. But it would REALLY reverse the share-price direction. So it's a good middle solution, right, FDA?
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