Cytodyn Inc (CYDY)

[masshysteria]

Bluefish1

These are the million dollar questions...

On the positive side, all the nonsense about any company being able to run any trial they want and the FDA does not care etc. is pure BS.

Even with safety proven, no one, FDA included, wants to put patients through trials (phase II and certainly III) without a reason to believe there would be potential benefit. Doctors are even more protective and will not sign up to medicate patients (especially in life threatening cases like Covid). OLE and eIND are further proof folks know its working. That gets shut down right away at the first sign of lack of efficacy. It is not saline and blood chemistry measurements and various trials (HIV etc.) prove there is efficacy (some known and significant, some yet to be measured).

No idea what will happen with the 140 patient extension and CD-16. I trust the CD-16 design better as it's based on agreement on measures/parameters that will provide qualitative and quantitative metrics on addressing LH syndrome effects. I don't see the environment for LH patients changing like it is for active Covid patients and provided the measures where thought out well and the more quantitative (i.e. objective) measures are incorporated, the better the chance for success.

I don't remember the specifics but believe this is a phase II? Not sure if it's a registrational trial but with Leronlimab's safety, if it shows efficacy, an effective FDA would provide approval or at a minimum EUA to start dealing with the millions of less than functional post Covid patients.

On the 140 extension I'm on the fence. Not for any concrete reason but at this point I don't trust that the 'system', and more so the players in it, are equipped (or focused, or interested, etc.) in doing the right things. We're going for reduced hospital stay and the duration is short (treatment + 28 days) so hopefully not much changing in the standard of care within that period - but the last couple of experiences left a mark that with all good intentions, minor things may change and afflict a major impact on the overall outcome. And that's without even considering the power of the bureaucrat :(

MH