Tuesday, October 06, 2020 9:24:06 AM
https://insiderfinancial.com/all-eyes-on-cytodyn-now-that-trump-has-covid-19/180495/
From the article.
There are only 3 COVID-19 leading therapeutics (Ampion, Tocilizumab, and Leronlimab) that are classified as shots. Ampion which is made by Ampio Pharmaceuticals (NASDAQ: AMPE) is currently classified as a shot but their COVID-19 product is likely to be via intravenous or a nebulizer. So they are a contender but Tocilizumab which is made by Roche Holding (OTCMKTS: RHHBY) failed to meet its endpoint in a phase 3 study.
The top pick and only the second drug to file for Emergency Use Authorization (EUA) during this pandemic is leronlimab. Filing a EUA means the drug company CytoDyn feels there is such a compelling case for approval of leronlimab that they are requesting the FDA to act now. It filed the request on August 17th and has received little to no fanfare from any of the major media outlets despite successfully reaching multiple endpoints in phase 2 clinical trial.
On the contrary, to great fanfare despite its shaky results, Gilead Sciences (GILD) was the first to file a EUA after it released “positive data” from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of remdesivir for COVID-19. The EUA was controversial because Gilead changed the endpoints and although Gilead classified remdesivir as an antiviral, the drug had no impact on the viral load, no effect on mortality, and a relatively small reduction in hospital stay. Additionally, the safety profile is not optimal. Despite these shortcomings, it was approved on May 1st which was two days after the results were released.
From the above I think it is quite clear and as many others have stated as well, that Lobbyism is the biggest factor here in getting a drug to market.
Well done to Leo if he was the driving force in getting B tested in combo with Remdesivir. none of these treatments in the article have as far as I know been tested in combo with remdesivir, which gives B in combo a much better chance of getting to market.
Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing had happened
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