Replies to post #18087 on Cytodyn Inc (CYDY)

[Saltz]

Thank you for your post Inoviorulez, I completely agree.

What is your opinion of CYDY from an investment perspective? Do you have a position, looking for an entry point, or simply making the point from the sidelines that often times management is not to blame for delays, but rather at the mercy of the FDA?

[gestalt2]

I agree, however i strongly feel the FDA does not have every right to do what ever it wants. It is a government entity whose job it is to monitor trials to make sure drugs do what they say they do, side effects are documented and the drug is safe. I realize this means that they have a lot of responsibility but when there is close to a year of setting the trial protocol they should own their agreements. The FDA said 30 patients for the combo and to think they can and without any explanation change this whenever they want is irresponsible. Cytodyn is a small biotech and these changes could mean a important drug never gets to market. I am sure many past drugs went through this and we do not have treatments available due to the finances required to make it happen. I am sure the FDA is aware of this but they are way behind in terms of solving this problem. Pro 140 has been in existence for 7+ years and it is as close to ever to being on the market but at a cost of many years and hundreds of millions to get here. The FDA has to answer to the HIV population as to why a drug that there is absolutely no safety issues for over 7 years and proven efficacy is being jerked around at the last minute by them.

[BlueHorseshoe13]

If the FDA examined the data and is looking for statistical relevance, it by definition means they are attempting to prove/dis-prove an anomaly. Meaning the early data is outside of the bell curve for established treatments. From that one could infer that the early results were not only good, but game changing. If the additional patients confirm this, well, the rest will be history. Best of luck to you all, and most importantly to all of those patients in need who may very soon have a life changing option.