To All:
I'm sure all of you believe me when I tell you this has been a busy and confusing weekend re Cytodyn.
To begin, I was 100% correct in my evaluation of the first press released Fri night.
The purpose of this memo is to evaluate the second press release combine them and present what in my opinion will happen during the next 60 days.
Leronlimab ( herein called DRUG) works on critically ill Covid patients. No "if's buts, or maybe's" it works!!!!!
1) Within the next few days the FDA and Cytodyn will agree on a protocol to administer the drug to 140 criticall patients suffering from Covid. The end point ( result that the test will determine) will be based on the following
Discharge alive: In addition, patients who received leronlimab demonstrated an improved probability of "discharged alive" at Day 28 .
Based on the test just completed the drug was better than the placebo by 166%
This new test will be successful. This new test results on the critically ill will be completed within a month. Results of the new test will be reported to us soon after.If all goes well we will know that we either will have an approved drug or a EUA approval within 6-8 weeks at best.
This disease is not going away!. The need for a powerful drug that will save lives will be around for many years.
The % of population that will refuse the drug will be over 10%. Magnify that worldwide, and you have a significant population that will need this drug. 6-8 weeks is a miniscule time to wait at this point in the development of this living saving drug.
Now you ask yourself the question Why doesn't the FDA approved this drug immediately to save lives?
The short answer- they still might give the drug "conditional approval" in the very near future.
They should!!! but don't count on it! why not?
Trail just completed was a trial for critical and ssevere patients
1) SEVERE IS NOT SYNONYMOUS WITH SERIOUS IN THE MEDICAL FIELD. IT IS MUCH LESS SERIOUS THAN CRITICAL. PLEASE KEEP THAT IN MIND.
Rather than going into complex reasoning it is sufficient to say the second press release wanted us to understand that under certain circumstances if we adjust age issues the drug was successful even for those with severe conditions.
The FDA does not do that. In their mind the test was for Critical and Severe and when you combine them the total score for the drug did not pass their testing requirements .
Here are the critical points
) The drug is in a class all by itself. There is nothing close to it to save lives for critically ill patients.
2) The drug will be approved for critical patients sooner rather than later
3)The drug will be in great demand for many years to come.
I have been an investor for too many years.
I know the "Ups and down's" of a stock especially in the bio tech field.
I have been an investor in this company for close to 8 years. Am I tired of management and their inability to get this wonder drug across the "finish line" you bet I am.
This set back is nothing unusual, happens all the time in the bio tech field. In fact we are now "ZERO IN"on the exact application that will allow us to be very successful.
Cancer Nash HIV and a host of other promising applications are still close to happening with this drug
Conclusion --In my opinion not sure what direction the stock will take tomorrow morning. Many people think the stock will be much lower. It is truly irrelevant as to your investment in Cytodyn if there is a lower price. For all the reasons I mentioned above, Monday is not the time to sell shares . Only my opinion