The FDA, PDUFA And You The Impatient Investor
So Friday came and went. The PDUFA date wasn't announced and I wasn't surprised. A lot of people took the word "SHOULD" and mistook it for meaning "absolutely will" from the prior announcement that CYDY SHOULD receive it's PDUFA on July 10th.
I said I expect it Tuesday, and COVID results on the 16th. But here is why you may not hear from the FDA as soon as you might think.
The FDA Is A Government Agency
Government agencies even in times of crisis move on a geologic timetable. The only time a government agency functions anything close to a do or die private enterprise is when budget season is around the corner and they need to dump every last dollar, or they have been embroiled in a major scandal and needs to poop Tiffany cuff links so everyone can protect their phoney baloney jobs to borrow from Mel Brooks.
CYDY Already Heard And Is Holding The News
Companies announce their PDUFA dates to the public, the FDA does not. The FDA merely communicates with the company.
So why hold the information? Well there are a few smart reasons to do this:
1. Hedge against bad news. If COVID results come back as crap, having a solid piece of good news like a PDUFA will balance it out.
2. If engaged in buyout talks, not announcing the PDUFA till after talks have concluded is a possibilty.
3. Use it and good COVID results to punish critics, shorts and have an "epic news day." Having good COVID results and PDUFA date announced together preferably at the start or end of the business week would create a frenzy. Even if you were a diehard short wanting to question the science, you still get blasted by that second barrel that is the PDUFA announcement.
My Guess Is Nader Is Holding Onto The Release
So my current line of thinking is even if the FDA is being slow, as Nader gets the information he is going to hold it. Why? Well I think he is a little pissed at the attacks on the company. I think he wants something big to hit critics and shorts with, and to shut up some of the more vocal investors who cram his inbox with emails. You have to remember thus far the attacks on CYDY have been mostly personal attacks on Nader. Andrew Left and Adam Fruerstein never did a deep dive into the science and decided to nitpick the CEO for not being a traditional Big Pharma CEO.
So if he is holding the information expect everything Friday. If not and the FDA is just being sluggish expect the announcement that the hospitals have signed off on the data.
In the meantime relax. You only lose money if you sell at a loss.
AI
