The FDA needs to get off it's ass. We need time to

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The FDA needs to get off it's ass. We need time to manufacture and they are squandering it.

Why aren't they helping us manufacture?

We're hoping UK steps up. But I still have found no information about how long it would take them to approve.

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In my opinion, that's the 'tell'. As far as we know, they are not helping us to manufacture. And in the context of the US spending money like a drunken sailor on anything that has even a 5% chance of working -- this speaks volumes.

We don't know if an OWS meeting took place -- or what was discussed. However, Dr.NP and team clearly do not sound like they know domestic M/M approval is a 'done deal', and that they are moving on to the UK MHRA simply because it is the next logical target to get approval from.

From my perspective, it's just the opposite. We are close-on to a month since the Unmet Need EUA was submited, and the FDA is saying nothing more than a vague claim to a response being "forthcoming". Dr.NP and team seem tired, frustrated and feeling pressured to get an approval from ANY other country.

It smells like Plan B to me. And that's why the confidential back-channel is not necessarily good for us. We've all discussed this before -- how it would be better for us to get an approval from a county that was not under the thumb of the FDA, Big Pharma, or the US government.

The meeting with the UK MHRA on Wednesday is to "discuss the Company’s request for Fast Track approval of leronlimab to treat COVID-19 patients with mild-to-moderate symptoms based upon the trial’s Top-line Report and additional eIND data."

Source Link: https://www.cytodyn.com/investors/news-events...fast-track

I don't know how long it might take for the MHRA to grant Fast Track status. What we do know is that once granted, the submission will be "Reviewed within 36 - 72 hours of submission".

Source Link: https://www.hra.nhs.uk/covid-19-research/fast...9-studies/

This is a familiar time frame, as it has been discussed several times in the past week or two. However, that review period is based on already having been granted Fast Track status -- and I don't believe that has happened yet.