Blafarm,
Thank you for the suggestion.
Wanted to explain to you why (only imho) the Update on enrolled patients of COVID P2b/3 Severe trial is #10: we will not be able to finalize this trial any time soon. The reason is very simple: the FDA has set up the bar very high for a company of the size of CytoDyn.
We need to make choices simply because we don't have enough resources. As we speak, we should be pursuing aggressively mTNBC, mBC, NASH, PrEP and Basket trials. Arguably more promising indications that COVID
We are not (with the speed we would like to).
Why? simply because of lack of resources.
NP has strategically devoted himself to COVID (rightly so) as is a lower-hanging and reachable fruit (maybe not the juicier one). Mild-to-moderate is doable to put the foot on the COVID door with the FDA.
Shouldn't FDA (or government) tell us: "listen, you are doing well and have a VERY promising and safe drug, here is some money so you can explore the possibility of reopening the economy fast by pursuing rapidly the Mild-to-Moderate and severe indications. We will facilitate things for you in light of the very pressing need for life-saving solutions and your proven MoA and science".
Yes, they should, but no they won't. Why ?? I don't want to tell you what I think because it really doesn't matter. It is what it is. We need to survive alone with what we have. P2 Mild-to-Moderate is a good, fast trial in which we can tell everybody: hey here we are and hey, it WORKS !!!!
That is why P2b/P3 Severe trial is at the bottom of my list. It will just not happen before anything else happens. Unless, of course, FDA has a come to Jesus moment.
Thank you for the suggestion.
Wanted to explain to you why (only imho) the Update on enrolled patients of COVID P2b/3 Severe trial is #10: we will not be able to finalize this trial any time soon. The reason is very simple: the FDA has set up the bar very high for a company of the size of CytoDyn.
We need to make choices simply because we don't have enough resources. As we speak, we should be pursuing aggressively mTNBC, mBC, NASH, PrEP and Basket trials. Arguably more promising indications that COVID
We are not (with the speed we would like to).
Why? simply because of lack of resources.
NP has strategically devoted himself to COVID (rightly so) as is a lower-hanging and reachable fruit (maybe not the juicier one). Mild-to-moderate is doable to put the foot on the COVID door with the FDA.
Shouldn't FDA (or government) tell us: "listen, you are doing well and have a VERY promising and safe drug, here is some money so you can explore the possibility of reopening the economy fast by pursuing rapidly the Mild-to-Moderate and severe indications. We will facilitate things for you in light of the very pressing need for life-saving solutions and your proven MoA and science".
Yes, they should, but no they won't. Why ?? I don't want to tell you what I think because it really doesn't matter. It is what it is. We need to survive alone with what we have. P2 Mild-to-Moderate is a good, fast trial in which we can tell everybody: hey here we are and hey, it WORKS !!!!
That is why P2b/P3 Severe trial is at the bottom of my list. It will just not happen before anything else happens. Unless, of course, FDA has a come to Jesus moment.
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