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Posted On: 08/21/2019 10:33:12 AM
Post# of 149724
My take away from the comment about 2 drug combo was they are trying to make a partnership with a BP that has an existing HIV pipline easier to digest. Any BP that partners/buys cytodyn has to explain to their shareholders why the investment in their current HIV pipline is now obsolete, which is not easy. It is also not going to be easy to explain how they let cytodyn get all the way through trials, approval and be on the market with their product and have there revenue take a huge hit without partnering/buyout when it was so cheap for so long. This is cytodyn building what the deal could look like with a 2 drug platform instead of the our product is better than yours and we will crush you type attitude.
Cytolin and Leronlimab were both originally to be approved as monotherapy drugs. The easiest and quickest path was originally to get them approved as a "holiday" drug so patients had an option to take a break from their normal drugs. The FDA is who required the combo trial approval before anything else. I think this was purely so they could compare apples to apples - all other HIV drugs are approved in combination so Leronlimab also had to. Ultimately this combo trial process will pay off because the mono trial does not have to prove itself in terms of safety or efficacy. In my opinion, the reason Nader talks of the mono trial as if getting the protocol approved is the most important milestone rather than the actual trial data and approval is because he knows that partnerships and buyouts happen before trials will be finished. The industry already knows Leronlimab works as a mono drug, the pivotal trial data will be no surprise. Getting the FDA to let them go for it shows that the FDA is ready for a mono drug and Cytodyn has it. BP must act once they know the FDA is green lighting this. Any concern about how long or how many patients are required does not matter much, just that the protocol is agreed on.
It is hard to really get the direction of cytodyn's grand plan. On one hand they are trying to make the combo approval more palletable to BP, on the other they are very close to showing their drug will make many existing drugs and piplines obsolete. My impression is that the message is formed as the deals and opportunities surface. I feel the whole "go at it alone" statements are purely to show they don't need a BP deal, even though they would rather have one.
Cytolin and Leronlimab were both originally to be approved as monotherapy drugs. The easiest and quickest path was originally to get them approved as a "holiday" drug so patients had an option to take a break from their normal drugs. The FDA is who required the combo trial approval before anything else. I think this was purely so they could compare apples to apples - all other HIV drugs are approved in combination so Leronlimab also had to. Ultimately this combo trial process will pay off because the mono trial does not have to prove itself in terms of safety or efficacy. In my opinion, the reason Nader talks of the mono trial as if getting the protocol approved is the most important milestone rather than the actual trial data and approval is because he knows that partnerships and buyouts happen before trials will be finished. The industry already knows Leronlimab works as a mono drug, the pivotal trial data will be no surprise. Getting the FDA to let them go for it shows that the FDA is ready for a mono drug and Cytodyn has it. BP must act once they know the FDA is green lighting this. Any concern about how long or how many patients are required does not matter much, just that the protocol is agreed on.
It is hard to really get the direction of cytodyn's grand plan. On one hand they are trying to make the combo approval more palletable to BP, on the other they are very close to showing their drug will make many existing drugs and piplines obsolete. My impression is that the message is formed as the deals and opportunities surface. I feel the whole "go at it alone" statements are purely to show they don't need a BP deal, even though they would rather have one.
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