Excellent Post! To build a little on it, I was res
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(Total Views: 555)
Posted On: 02/22/2021 10:41:37 AM
Excellent Post! To build a little on it, I was researching what the material disclosures are for this situation. I found plenty of legal cases involving when and what a publicly traded sponsor company discloses. It is interesting that the DSMC has a very important job beyond the safety of trial participants, they also are a 3rd party that can shield material information that the sponsor company would have to disclose. Also, it seems that lawsuits typically involve the sponsor company having material info and disclosing either too much or too little of it AND the result involved the investors losing money. The typical pattern is that the sponsor company is under no obligation to connect the dots for the investors.
It is obvious that the law firm for Cytodyn is doing overtime to make sure information is not in a material state requiring disclosure so the trial can keep its integrity. Raw data could easily be read many ways and Cytodyn obviously is only interested in the FDA's way of reading it - as they should. I have no doubt the FDA is well aware of how this needs to be handled and to give a good example, look how the mild to moderate trial was handled. In that case Cytodyn really did make it seem a P2 trail would get an EUA and clearly the FDA did not feel that way. Compare that to this trial and Cytodyn is going with as little info as possible to make sure the primary goal of an EUA does not sail away with a bunch of lawsuits being filed on top of it.
Bottom line, in my opinon, If the data was not good, they would be saying more mostly because that is the protection you need from lawsuits. Saying less rarely leads to a lawsuit if the data is good.
It is obvious that the law firm for Cytodyn is doing overtime to make sure information is not in a material state requiring disclosure so the trial can keep its integrity. Raw data could easily be read many ways and Cytodyn obviously is only interested in the FDA's way of reading it - as they should. I have no doubt the FDA is well aware of how this needs to be handled and to give a good example, look how the mild to moderate trial was handled. In that case Cytodyn really did make it seem a P2 trail would get an EUA and clearly the FDA did not feel that way. Compare that to this trial and Cytodyn is going with as little info as possible to make sure the primary goal of an EUA does not sail away with a bunch of lawsuits being filed on top of it.
Bottom line, in my opinon, If the data was not good, they would be saying more mostly because that is the protection you need from lawsuits. Saying less rarely leads to a lawsuit if the data is good.
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