So this is what we NOW know: the Long Haulers in the LH trial who were given Leronlimab fared much better than the ones who were given a placebo.
We also NOW know that those patients who were given Leronlimab were temporarily healed of most of their symptoms. Some have recently stated that symptoms are returning. So Leronlimab does work - just like we thought before the FDA letter - some have believed in LL for more than five years.
Why am I stating this? Because, instead of highlighting LL's benefits, we keep reading about NP's shortcomings.
Furthermore, I would like to ask, when was the last time that there was an efficacious therapy for Long Haulers?
I know that is really a stupid question but hear me out.
Of course, the answer is: Covid has been around for only eighteen months. So there hasn't been an efficacious therapy for Long Haulers. Besides, maybe since October of 2020 have some in the medical field acknowledged that there is a malady called "Long Haulers."
This begs the question: has the FDA seen this type of malady before?
Another stupid question but it must be asked.
No, the FDA has not seen this type of malady.
So what are the protocols for this malady - (I think it's called PASC).
Again there are none, yet. They're coming, but not here yet.
The FDA recently spanked CytoDyn for claiming endpoints that do not exist but if the FDA does not have protocols in place for PASC, which is in CytoDyn's wheelhouse, how can it justify that critique?
Furthermore why criticize NP when we are standing on the threshold of an undiscovered malady with no protocols in place. Is it possible that it is not NP's fault? He looks like he is bumbling around but that's because the FDA is bumbling MORE.
The protocols for PASC are now going to be initialized/authorized due to the FACT of this trial. CytoDyn's trial.
Did NP have anything to do with this trial?
My point is: all those who have been critical of NP in the past have placed the cart before the horse.
This PASC hell-hole was recently dense wilderness until Leronlimab. The FDA is about to clear a path due to NP, CytoDyn's workforce, and the Long Haulers who participated in the first ever trial.
Look how long that took, or short depending on one's optimism or pessimism.
In conclusion, NP is not the problem. Read on: The Pharma Industry is highly-regulated. Protocols are put in place to keep people safe. It takes much time, bureaucratically, to ensure a drug is safe.
NP has taken the first step - took quite a bit of time despite the enormous pressure to get things done. Now we want him to file BLA's and start other trials - just remember this is a highly regulated industry. NP is beholden to regulations and a myriad of rules.
Be safe.
