My open letter to Mrs Woodcock today:
Dear Mrs Woodcock,
I am 57 and served as a graduated Chemical Engineer for 45 years in the industry. P-Value (we used more the expression "2 sigmas") is very well known in the industry and widely used for reporting results of trial or specifications of warranties. It is an important indicator - no doubt!
In the past, you said that clinical results are more important than p-value, and I fully agree with you if we deal with life and not with machines, then we need a more comprehensive approach than just a narrow view which p-value gives us.
How can you take now in the case of Leronlimab the approach that "p-value matters more than lives"? We are not talking about 1 or 2 (which are also important, of course) but the ten- thousands of lives as all other countries are waiting for FDA- approval.
The results of CD12 are talking for themselves. Over and above, I believe strongly, as shown in CD10 by News 2 results, which FDA irresponsible dismissed and instead of it approved worthless Remdesivir, most of the patients would never "arrive" in the severe condition when given in time Leronlimab. Do the great number of lives you could safe not count? Does the significant reduction of hospitalisation days (in case of Remdesivir 1 day reduction- disagreed by WHO- was enough) not count, not because of money but by indirectly increasing the emergency rooms' capacity?
I send you enclosed an article which I agree with in full content.
May God enlighten you NOW and not hold on to Your LAST DAY accountable for the death you are responsible for by appreciating the p-value more than lives. May no- one of your loved ones around you or even you not desperately need Leronlimab instead of "killing" Remdesivir or less effective Dexamethasone.
It's not yet too late to give a conditional EUA with a following up phase 4. You know all the results, you know Leronlimab is working, why are you not following your conscience? A machine or a robot without AI would decide for p-value, but you should decide for lives.
Yours faithfully
