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Why Am I Confident (although still anxious) eIN

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Post# of 153869
(Total Views: 572)
Posted On: 02/25/2021 10:34:54 PM
Posted By: calstang
Re: calstang #80008
Why Am I Confident (although still anxious)

eIND and Open Label Extension use of Leronlimab has not been halted by FDA

It has been very quiet since the end of s/c Trial enrollment. And they are talking about something, and it certainly is not talk about how to deliver the bad news

Has anything negative been announced about Leronlimab's s/c trial data?

A firm's CEO has legal disclosure obligation of information that might have a ‘material’ impact on the sponsor company's revenues.

Cytodyn is in talks regarding Leronlimab's approval, with the US, Canada and the UK.

Numerous countries are in urgent need of a drug to reduce the death rate of patients with s/c covid-19

We expect to meet our s/c Primary Endpoint at the 28 day data analysis, with reduction in death rate by 30% to about 50%.

The FDA appears willing to look at 42 day data or even 60 day data if necessary for Leronlimab to achieve Stat Significance and a p value <0.05

GSK trial reported today (SA) 40.4% death rate in placebo SOC group at 60 days.



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