Everyone seems to think that a "halt for efficacy" has been ruled out. Maybe, and it's a big maybe, it is now less likely. But, maybe not.
Consider that halting a trial for efficacy is a big decision, a decision that once made, you cannot go back. The only way to go back on such a decision is to start the entire clinical trial over from scratch.
If you halt it on a DSMB recommendation, remember that it is merely a recommendation, it is still the sponsor, that would be CytoDyn, that is on the hook for the decision, good or bad.
If you just halt upon receipt of the DSMB recommendation, without careful analysis of your options, and the FDA then says, but....you should have continued it a little longer, you just ruined your clinical trial, and as I said above, must start the entire trial from scratch again!
Remember the DSMB is not the FDA, and they are not a superpower committee that can overrule the FDA. The FDA rules on everything.
If you get a halt for efficacy recommendation, you will go through every last detail over and over until convinced that it is the right thing to do. I am not an expert, but I would guess that you would attempt to take it to the FDA and get their approval before halting.
What you certainly are not going to do is immediately actually halt for efficacy and end the clinical trial, or even move all the placebos patients to active drug. Seems you would need FDA approval for that.
Let's run through a hypothetical that last week (on Wednesday or Thursday) CytoDyn received a recommendation from the DSMB to halt for efficacy, what do you do?
Can you halt immediately? No, don't think so, see above.
You probably study the issue and seek FDA guidance, see above.
Crucially, you need to say something to the shareholders, but what can and should you say, and what are you required and prohibited from saying?
Do you actually immediately tell the public in a PR that the DSMB said they recommend a halt for efficacy? Can you really say that immediately without first thoroughly studying the issue and attempting to vet it through the FDA? What if you made such a PR, and it turns out that the right course is not to follow the recommendation?
But, let's say that you believe and have been told it will take half a week to study the issue and present it to the FDA. What does your PR say?
I propose that your PR would be a bland vanilla no frills PR similar to the one that was issued last Thursday evening, scheduling a CC for this week, suggesting there is a regulatory path forward, set for a time that the company can inform the shareholders of not only the recommendations, but what they have actually decided to do with regard to the recommendations.
(Caveat: I know no more than you what is going on here. I am not an expert in any of this. These are merely my rambling thoughts this evening on this topic. I had glass of wine with dinner.)
Consider that halting a trial for efficacy is a big decision, a decision that once made, you cannot go back. The only way to go back on such a decision is to start the entire clinical trial over from scratch.
If you halt it on a DSMB recommendation, remember that it is merely a recommendation, it is still the sponsor, that would be CytoDyn, that is on the hook for the decision, good or bad.
If you just halt upon receipt of the DSMB recommendation, without careful analysis of your options, and the FDA then says, but....you should have continued it a little longer, you just ruined your clinical trial, and as I said above, must start the entire trial from scratch again!
Remember the DSMB is not the FDA, and they are not a superpower committee that can overrule the FDA. The FDA rules on everything.
If you get a halt for efficacy recommendation, you will go through every last detail over and over until convinced that it is the right thing to do. I am not an expert, but I would guess that you would attempt to take it to the FDA and get their approval before halting.
What you certainly are not going to do is immediately actually halt for efficacy and end the clinical trial, or even move all the placebos patients to active drug. Seems you would need FDA approval for that.
Let's run through a hypothetical that last week (on Wednesday or Thursday) CytoDyn received a recommendation from the DSMB to halt for efficacy, what do you do?
Can you halt immediately? No, don't think so, see above.
You probably study the issue and seek FDA guidance, see above.
Crucially, you need to say something to the shareholders, but what can and should you say, and what are you required and prohibited from saying?
Do you actually immediately tell the public in a PR that the DSMB said they recommend a halt for efficacy? Can you really say that immediately without first thoroughly studying the issue and attempting to vet it through the FDA? What if you made such a PR, and it turns out that the right course is not to follow the recommendation?
But, let's say that you believe and have been told it will take half a week to study the issue and present it to the FDA. What does your PR say?
I propose that your PR would be a bland vanilla no frills PR similar to the one that was issued last Thursday evening, scheduling a CC for this week, suggesting there is a regulatory path forward, set for a time that the company can inform the shareholders of not only the recommendations, but what they have actually decided to do with regard to the recommendations.
(Caveat: I know no more than you what is going on here. I am not an expert in any of this. These are merely my rambling thoughts this evening on this topic. I had glass of wine with dinner.)
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