Friday, November 06, 2020 7:23:38 AM
https://insiderfinancial.com/cytodyn-otcmkts-cydy-accelerates-recruitment-to-250-patients-in-pivotal-covid-19-trial/180653/
INVESTMENT SUMMARY
Investors have been waiting for months for approval but it never seems to materialize. The company finished its mild to moderate CD10 trial and it was the first drug to score statistical relevance in a COVID-19 trial yet the FDA was against issuing an EUA. The latest move by the DSMB indicated that leronlimab was tracking to meet its primary endpoint of 28 day all cause mortality. This is only pivotal stage clinical trial with mortality as an endpoint. A reduction in mortality is the gold standard in clinical trials. Many investors are fatigued and thinking what is it going to take? The CEO has clearly telegraphed a lot of news is about to break in the near future but investors have their eyes fixated on an EUA. An EUA is a big deal but the FDA made it clear that they could make a ruling on that as soon as the next interim readout at 75% enrollment. The proper perspective for investors is that quick enrollment could lead to quick approval. There seems to be a very strong case that enrollment is going to skyrocket in the near future. If that is in fact the case then shareholders should be gobbling up shares at these discounted levels. It seems very clear that an approval is just around the corner and could come from the MHRA or the Americans.
Recent CYDY News
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