Poster blasts FDA for delaying Covid drug which has outstanding results at mayo Clinic.
cowtown jay Member Level Thursday, 09/16/21 08:37:00 AM
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Post #
33448
of 33519
No, FDA, Humanigen's lenzilumab is not "too good to be true." But it is true, to the families, of the patients who are dying of Covid without this drug.
If YOU want more information, you're part of the same HHS that the NIH is. Why aren't you evaluating their data, on the retrospective basis Humanigen used, on the 200 patients they tested, which was good enough for the NIH to advance the trial?
And why should the NIH be worried about a placebo arm in their extended trial? Why aren't they administering lenz to all patients? Or do you really need more information of how standard of care patients fared?
You should have approved, really, you should approve, this drug, on the basis of the demonstrated results. You can monitor the results of the on-going NIH trial and pause the use of lenz, if you deem it necessary, from information discovered in that in-progress trial.
You are not only causing the preventable deaths of US patients, you are also placing an American business, and its shareholders, in an unfair competitive disadvantage.
