“Instead of counting how many people taking the drug were kept alive on ventilators or died, among other measures, the National Institute of Allergy and Infectious Diseases said it would judge the drug primarily on a different outcome: how long it took surviving patients to recover.”
There is little doubt in my mind that Gilead heavily influenced the decision to change the endpoint in this trial despite Gilead claiming that the government researchers were responsible for the switch. Why do I say that? There’s another Gilead antiviral that was approved by the FDA after a trial showed that the duration of symptoms of the flu was reduced by taking the drug: oseltamivir, also known as Tamiflu (licensed to Roche).
If your not familiar with Tamiflu, similar to remdesevir, the drugs clinical trial results and end points were, and continue to be, heavily debated. Tamiflu reduced the duration of symptoms in clinical trials but many debate whether use of the drug reduced hospitalizations and deaths (which is more important than reducing symptoms by less then 24 hours). There have been many independent clinical studies on Tamiflu since the original trials that showed the drug didn’t reduce hospitalizations or the death. If you review annual flu deaths from the 1970s through 2019, there is no major reduction in deaths following approval of Tamiflu in 1999. In my clinic and across medicine, there is a divide of those who use the drug because they believe it works and those who don’t believe it works, but prescribe the drug on occasion, more so when patients request it (I believe Tamiflu has a strong placebo effect). Tamiflu also has common side effects such as diarrhea, vomiting and headache, which can make influenza worse for people with mild symptoms. Many medical providers prescribe antiemetics and antidiarrials with Tamiflu because of these side effects.
My point, and a point that has been discussed here and in the news, is this: remdesevir is a temporary bandaid that may provide “hope” to the country and give providers a drug to give to COVID19 patients. Reducing the duration of symptoms might get people back to work sooner (that’s debatable as well), but if the drug doesn’t reduce hospitalizations or deaths, it’s not much of treatment for future COVID19 pandemics (if the virus returns next fall, etc.)
Leronlimab can still be the breakthrough drug for COVID19 if CYDY can get the trials enrolled quickly and get the results to the FDA and published for all medical professionals to read. Additionally, leronlimab may be the drug that can be used to treat influenza. 40k-60K deaths per year in the U.S. alone, and many more worldwide, is unacceptable and I believe that in a few years from now, maybe somber, we’ll see an NIH funded trial for leronlimab in high risk patients diagnosed with influenza (young children, the elderly, and those with comorbidities). But until then, we as investors play the game of waiting for official trial data, funding and everything in between.
There is little doubt in my mind that Gilead heavily influenced the decision to change the endpoint in this trial despite Gilead claiming that the government researchers were responsible for the switch. Why do I say that? There’s another Gilead antiviral that was approved by the FDA after a trial showed that the duration of symptoms of the flu was reduced by taking the drug: oseltamivir, also known as Tamiflu (licensed to Roche).
If your not familiar with Tamiflu, similar to remdesevir, the drugs clinical trial results and end points were, and continue to be, heavily debated. Tamiflu reduced the duration of symptoms in clinical trials but many debate whether use of the drug reduced hospitalizations and deaths (which is more important than reducing symptoms by less then 24 hours). There have been many independent clinical studies on Tamiflu since the original trials that showed the drug didn’t reduce hospitalizations or the death. If you review annual flu deaths from the 1970s through 2019, there is no major reduction in deaths following approval of Tamiflu in 1999. In my clinic and across medicine, there is a divide of those who use the drug because they believe it works and those who don’t believe it works, but prescribe the drug on occasion, more so when patients request it (I believe Tamiflu has a strong placebo effect). Tamiflu also has common side effects such as diarrhea, vomiting and headache, which can make influenza worse for people with mild symptoms. Many medical providers prescribe antiemetics and antidiarrials with Tamiflu because of these side effects.
My point, and a point that has been discussed here and in the news, is this: remdesevir is a temporary bandaid that may provide “hope” to the country and give providers a drug to give to COVID19 patients. Reducing the duration of symptoms might get people back to work sooner (that’s debatable as well), but if the drug doesn’t reduce hospitalizations or deaths, it’s not much of treatment for future COVID19 pandemics (if the virus returns next fall, etc.)
Leronlimab can still be the breakthrough drug for COVID19 if CYDY can get the trials enrolled quickly and get the results to the FDA and published for all medical professionals to read. Additionally, leronlimab may be the drug that can be used to treat influenza. 40k-60K deaths per year in the U.S. alone, and many more worldwide, is unacceptable and I believe that in a few years from now, maybe somber, we’ll see an NIH funded trial for leronlimab in high risk patients diagnosed with influenza (young children, the elderly, and those with comorbidities). But until then, we as investors play the game of waiting for official trial data, funding and everything in between.
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