We are ad portas of important events for CytoDyn. Both P2 M-M and P2b/3 C-S COVID trials are potential the first possible clinical approvals in the company’s life.
Last week the stock price went up 88.3% following a parabolic trend when new, deep-pocket participants (60.834.095 shares traded in five days) entered the fray in anticipation for upcoming good news and the acceptance that existing shareholders had lifted the stock to the “non penny stock anymore” category. We sit close to $7 dollars and, given the large potential market and pressing economical influence, the valuation has way to go if the drug is approved for any of the indications,
What to expect??
Well … hopefully good news . But we need to differentiate M-M and S-C, as the former is P2, the latter is P3.
What we need in both is simply put, and in NP words: to crush the p-value. Period.
In both trials, and in a normal world, we should be finishing M-M P2 and then go to a more extensive P3, and in the S-C we should finish the enrollment of 390 patients afer having a peek at the interim 50 patient results.
But these are not normal times: people are dying in droves all over the world, mostly in the Americas; some countries are expecting a second wave in the fall-winter, and the USA has not even shaken off the first wave with the grim perspective of a very dark winter.
And the economy is in a stand-still. Not to insult anybody’s intelligence, but we need a drug fast and FDA knows it.
So … back to reality. In the C-S trial having the same amount of deaths on the placebo and Leronlimab trial (remember, there are double patients in our cohort) will produce a statistical significant value, but imo this will not be enough. More specifically: assuming an average death rate of 35% 6 patients will not make it in the placebo group. We need to show the survival of all but two or less patients in our group (p-value = 0.0083).
My rationale is that a value less than 0.01 will put the FDA in a situation when it cannot negate stopping the trial and approving Lero’s usage for showing undeniable efficacy.
In regards to the M-M trial: we are in P2 and, once again, we need to show the FDA that the drug works better than any other tested so far in critical placebo-controlled trials. This is test is more difficult to ascertain, but, at the same time, gives us more opportunities to “hit it out of the park”, so to speak. Namely, my simulations show that, if the mean difference of our clinical outcomes at the end of 14 days is less than 1 (remember, we have a scale of 4 for each of 4 conditions) than that of the placebo control, assuming a standard deviation of 1.43, we will crush the p-value. I personally think that we can readily do this if the outcomes show what the measurements have been showing so far. Also, we will have hard-core supporting evidence of the outcomes with all the tests that IncelRx has carried out, and, therefore, think that this trial presents a very promising outcome.
Can FDA ignore stunning results?? Yes. I am not a believer of the fairness of FDA (I know some members of this board disagree with this and that is fine with me
) for reasons that will take a large space to explain and will take us to some rabbit holes. Simply put: imo BP’s money has tainted it. The same way lobbyists have tainted a fair-participative process in Washington. But that is another story.
We need to do our part, that is simply to PRODUCE OUTSTANDING CLINICAL OUTCOMES.
The rest we cannot control.
Next few weeks will tell the tale. Good luck to you all and more to the old-timers (those who where buying all the way down to December of last year) who do not need the money, but the vindication on the DD of the science.
Last week the stock price went up 88.3% following a parabolic trend when new, deep-pocket participants (60.834.095 shares traded in five days) entered the fray in anticipation for upcoming good news and the acceptance that existing shareholders had lifted the stock to the “non penny stock anymore” category. We sit close to $7 dollars and, given the large potential market and pressing economical influence, the valuation has way to go if the drug is approved for any of the indications,
What to expect??
Well … hopefully good news . But we need to differentiate M-M and S-C, as the former is P2, the latter is P3.
What we need in both is simply put, and in NP words: to crush the p-value. Period.
In both trials, and in a normal world, we should be finishing M-M P2 and then go to a more extensive P3, and in the S-C we should finish the enrollment of 390 patients afer having a peek at the interim 50 patient results.
But these are not normal times: people are dying in droves all over the world, mostly in the Americas; some countries are expecting a second wave in the fall-winter, and the USA has not even shaken off the first wave with the grim perspective of a very dark winter.
And the economy is in a stand-still. Not to insult anybody’s intelligence, but we need a drug fast and FDA knows it.
So … back to reality. In the C-S trial having the same amount of deaths on the placebo and Leronlimab trial (remember, there are double patients in our cohort) will produce a statistical significant value, but imo this will not be enough. More specifically: assuming an average death rate of 35% 6 patients will not make it in the placebo group. We need to show the survival of all but two or less patients in our group (p-value = 0.0083).
My rationale is that a value less than 0.01 will put the FDA in a situation when it cannot negate stopping the trial and approving Lero’s usage for showing undeniable efficacy.
In regards to the M-M trial: we are in P2 and, once again, we need to show the FDA that the drug works better than any other tested so far in critical placebo-controlled trials. This is test is more difficult to ascertain, but, at the same time, gives us more opportunities to “hit it out of the park”, so to speak. Namely, my simulations show that, if the mean difference of our clinical outcomes at the end of 14 days is less than 1 (remember, we have a scale of 4 for each of 4 conditions) than that of the placebo control, assuming a standard deviation of 1.43, we will crush the p-value. I personally think that we can readily do this if the outcomes show what the measurements have been showing so far. Also, we will have hard-core supporting evidence of the outcomes with all the tests that IncelRx has carried out, and, therefore, think that this trial presents a very promising outcome.
Can FDA ignore stunning results?? Yes. I am not a believer of the fairness of FDA (I know some members of this board disagree with this and that is fine with me
) for reasons that will take a large space to explain and will take us to some rabbit holes. Simply put: imo BP’s money has tainted it. The same way lobbyists have tainted a fair-participative process in Washington. But that is another story. We need to do our part, that is simply to PRODUCE OUTSTANDING CLINICAL OUTCOMES.
The rest we cannot control.
Next few weeks will tell the tale. Good luck to you all and more to the old-timers (those who where buying all the way down to December of last year) who do not need the money, but the vindication on the DD of the science.
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