Dave Knapp
๐ค SpeakerAppearances Over Time
Podcast Appearances
So the trisepatide lawsuit has not evolved the way that I maybe thought it would based upon the judge, but we actually had a correspondent sit in on the one physical hearing that took place and he kind of gave me a call afterwards, gave me the rundown. He goes, this judge is extremely annoyed by the fact that this, that this, is even in his courtroom.
He knows that whatever the outcome, it's going to an appeals court, and he just doesn't think it belongs in this venue. Well, that didn't play well for compound terzepatide. It didn't bode well for the case for people who were relying on that mass-produced peptide. And it's sort of played out that way.
He knows that whatever the outcome, it's going to an appeals court, and he just doesn't think it belongs in this venue. Well, that didn't play well for compound terzepatide. It didn't bode well for the case for people who were relying on that mass-produced peptide. And it's sort of played out that way.
He knows that whatever the outcome, it's going to an appeals court, and he just doesn't think it belongs in this venue. Well, that didn't play well for compound terzepatide. It didn't bode well for the case for people who were relying on that mass-produced peptide. And it's sort of played out that way.
He denied the preliminary injunction last week, which essentially would have protected compounders until this trial was resolved. He denied that. And then he actually went one step further and moved for a summary judgment, which essentially means both sides are going to get a couple weeks to respond back and forth to his decision. declaration of a summary judgment and then he's just going to rule.
He denied the preliminary injunction last week, which essentially would have protected compounders until this trial was resolved. He denied that. And then he actually went one step further and moved for a summary judgment, which essentially means both sides are going to get a couple weeks to respond back and forth to his decision. declaration of a summary judgment and then he's just going to rule.
He denied the preliminary injunction last week, which essentially would have protected compounders until this trial was resolved. He denied that. And then he actually went one step further and moved for a summary judgment, which essentially means both sides are going to get a couple weeks to respond back and forth to his decision. declaration of a summary judgment and then he's just going to rule.
There won't even be a trial, witnesses, whatever. He just wants it out of his court. As luck would have it, he's the one who drew the subsequent lawsuit that was filed by the OFA against the FDA in the semaglutide shortage. So he's overseeing that case as well. It was a little interesting at first. Novo tried to interject
There won't even be a trial, witnesses, whatever. He just wants it out of his court. As luck would have it, he's the one who drew the subsequent lawsuit that was filed by the OFA against the FDA in the semaglutide shortage. So he's overseeing that case as well. It was a little interesting at first. Novo tried to interject
There won't even be a trial, witnesses, whatever. He just wants it out of his court. As luck would have it, he's the one who drew the subsequent lawsuit that was filed by the OFA against the FDA in the semaglutide shortage. So he's overseeing that case as well. It was a little interesting at first. Novo tried to interject
uh they're local they have to have local representation and they're a danish company so they hired a guy outside of the jurisdiction and so they he kind of slapped him down initially but novo was eventually able to join that lawsuit just like lily joined the terzapatide lawsuit to defend the fda's decision and so it's the ofa versus the fda and lily and the ofa versus the fda and novo
uh they're local they have to have local representation and they're a danish company so they hired a guy outside of the jurisdiction and so they he kind of slapped him down initially but novo was eventually able to join that lawsuit just like lily joined the terzapatide lawsuit to defend the fda's decision and so it's the ofa versus the fda and lily and the ofa versus the fda and novo
uh they're local they have to have local representation and they're a danish company so they hired a guy outside of the jurisdiction and so they he kind of slapped him down initially but novo was eventually able to join that lawsuit just like lily joined the terzapatide lawsuit to defend the fda's decision and so it's the ofa versus the fda and lily and the ofa versus the fda and novo
And so, you know, it's just it's not going to bode well. Both both of the mass produced compound versions will be going away. This will they filed the OFA filed an appeal in the Fifth Circuit, but that will take a long time to resolve and resolve. It's unclear whether the Fifth Circuit will do anything to sort of stay enforcement.
And so, you know, it's just it's not going to bode well. Both both of the mass produced compound versions will be going away. This will they filed the OFA filed an appeal in the Fifth Circuit, but that will take a long time to resolve and resolve. It's unclear whether the Fifth Circuit will do anything to sort of stay enforcement.
And so, you know, it's just it's not going to bode well. Both both of the mass produced compound versions will be going away. This will they filed the OFA filed an appeal in the Fifth Circuit, but that will take a long time to resolve and resolve. It's unclear whether the Fifth Circuit will do anything to sort of stay enforcement.
So my prediction of what's going to happen is you're going to see the mass compounding go away of both terzepatine and semaglutide. Everybody's going to move back to these 503As, which from my perspective is just, there's a spectrum here, right? There's a spectrum of non-branded medications. The...
So my prediction of what's going to happen is you're going to see the mass compounding go away of both terzepatine and semaglutide. Everybody's going to move back to these 503As, which from my perspective is just, there's a spectrum here, right? There's a spectrum of non-branded medications. The...
So my prediction of what's going to happen is you're going to see the mass compounding go away of both terzepatine and semaglutide. Everybody's going to move back to these 503As, which from my perspective is just, there's a spectrum here, right? There's a spectrum of non-branded medications. The...
big pharmaceutical companies would want you to believe that all non-branded are created equal they're just not right so 503 b's are subject to the current goods and manufacturing process long way of saying they have fda oversight when you move to 503 a's and that's kind of what we explained earlier where you take the active ingredient and then you you do it in a dose that isn't available commercially or you add b12 because somebody has