“Interesting strategic move to announce this com
Post# of 153903
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Posted On: 05/18/2020 1:02:56 PM
“Interesting strategic move to announce this combo trial. I don't think it will ever happen”
Many are labeling the PR today as a strategic move or a move to bring publicity to the CYDY/leronlimab COVID19 indication. I somewhat disagree.
NP mentioned that CYDY had been approached by an entity in FEB/MAR to conduct a combination trial with leronlimab. He didn’t mention the drug at the time, but he did say they weren’t interested in a combination trial. He later stated that if CYDY was approached about a combination therapy with remdesivir, he’d propose the idea to the board and they would make a decision. Then, last week, NP mentions that Mexico wants to run a trial that includes an arm for remdesivir, leronlimab and a combination of the two. Given this history, I don’t think the PR is simply a strategic move or meant to bring attention to leronlimab’s results in COVID19. Remember, results so far from the 54 EIND COVID19 patients is considered anecdotal so I don’t think CYDY would purposefully draw attention to themselves with a PR until at least data from the phase 2 for mild/moderate is complete.
From the history I posted above, it appears a third party has offered to run a trial of the two drugs and CYDY agreed to run that trial and thus, submitted the protocol to the FDA for approval. I have no doubts the FDA will approve the trial as a MAB has been touted as a great candidate to be combined with an anti-viral as the standard of care for COVID19.
My questions in regards to the trial:
1. Who is funding the trial? This will no doubt be an expensive trial and I don’t think CYDY has the funds at this time to find and fill a trial with 3 separate arms. Are there U.S. or foreign government grants involved?
2. Did GILD agree to this trial? Do they need to agree? I’d hope they’re on board to help with funding and supply of their drug.
I’m assuming we’ll have a proactiv video today that may address some of our questions.
Many are labeling the PR today as a strategic move or a move to bring publicity to the CYDY/leronlimab COVID19 indication. I somewhat disagree.
NP mentioned that CYDY had been approached by an entity in FEB/MAR to conduct a combination trial with leronlimab. He didn’t mention the drug at the time, but he did say they weren’t interested in a combination trial. He later stated that if CYDY was approached about a combination therapy with remdesivir, he’d propose the idea to the board and they would make a decision. Then, last week, NP mentions that Mexico wants to run a trial that includes an arm for remdesivir, leronlimab and a combination of the two. Given this history, I don’t think the PR is simply a strategic move or meant to bring attention to leronlimab’s results in COVID19. Remember, results so far from the 54 EIND COVID19 patients is considered anecdotal so I don’t think CYDY would purposefully draw attention to themselves with a PR until at least data from the phase 2 for mild/moderate is complete.
From the history I posted above, it appears a third party has offered to run a trial of the two drugs and CYDY agreed to run that trial and thus, submitted the protocol to the FDA for approval. I have no doubts the FDA will approve the trial as a MAB has been touted as a great candidate to be combined with an anti-viral as the standard of care for COVID19.
My questions in regards to the trial:
1. Who is funding the trial? This will no doubt be an expensive trial and I don’t think CYDY has the funds at this time to find and fill a trial with 3 separate arms. Are there U.S. or foreign government grants involved?
2. Did GILD agree to this trial? Do they need to agree? I’d hope they’re on board to help with funding and supply of their drug.
I’m assuming we’ll have a proactiv video today that may address some of our questions.
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