My initial reaction to yesterday’s CC was similar to the reaction of many posters. However, through all of the negatives let’s take a moment and look at what was stated and how the meeting went versus our expectations.
Michael read the disclaimer which I trust by now everyone understands is standard practice for all such meetings in all companies. I will bet that this is taken out of context and a reason to cast doubt on CYDY.
Secondly, they had some well renown doctors review their experience with Leron and all had very positive messages.
It is clear that NP and the team are now reluctant to offer dates. Either way the message is misconstrued so why give dates. We have beat them up on this.
Now the big issue. We all expected that CYDY filed for EUA On the M/M data. That was my understanding and truly the crux of my negative reaction. To me it is evident that CYDY is working with the FDA and the guidance is not to apply for the M/M EUA as few die at this stage. Rather the FDA wants to see the interim data as the S/C cases are truly the patients that need immediate help. CYDY is looking for assurance that if they apply it will be approved. It is also my understanding that the FDA upon review of the data can stop the trial and issue an EUA without the application.
It is also clear that the MHRA is looking at this closely and asking for pertinent data.
Both of these are positives! The interim data should be released next week and it will take some time to review the data before an announcement.
It was also stated that there are M/M patients with lingering symptoms. It was my understanding that no company has begun trials for this group and CYDY is moving in that direction also.
Again a very positive step!
NExt is the BLA for HIV. CYDY and the FDA have met and agreed on the data set that is needed for the final submission/response. Again we are merciless when they misss dates so suffice it to say that it is in process and looks positive!
Let’s skip the Nash details and leave it at the phase 2 trial is under way and they are optimistic.
Also the Gilead discussion was mostly anecdotal.
To me the most interesting discussion was regarding the blood brain barrier. They have good evidence to support their optimism and if it is indeed true this could be the biggest medical advancement since penicillin.
I want to be a part of that success.
This also answers the money issue. They have money and can get money but not necessarily on the best terms. The science is solid regardless of the negative posts. However, if I was a major financial institution lending the money I would demand that my CEO replace NP and call the shots. CYDY could also be sold which would also replace NP.
Lastly, NP is a fighter and does not appear to be running away. That said you can see that all the negativism is taking its toll. He has done a fantastic job to this point and is clawing his way through the issues. However he is not a great spokesperson and is not the leader that is needed now. As a minimum he needs a corporate coach.
Other than the disconnect delivery and emotional outbursts which are typical for NP the message was very positive.
Shorts and day traders will have a field day with CYDY for some time but CYDY is not flooding up and going away. If you are an investor looking for a quick hit this is the wrong place. I am long and plan to ride it out but it will be a difficult ride.
AI
