Shut up and follow the script!
Imagine a very small
Shut up and follow the script!
Imagine a very small biotech fighting openly with the FDA over their single life saving drug. The CEO was fired by the board. An established, respected CEO who had successfully dealt with the FDA in the past was brought in. The replacement CEO got the little biotech's first drug approved.
The little biotech was SRPT. Chris Garabedian was replaced by Ed Kaye and a little over a year later Etiplirsen received FDA approval. This all transpired between 2011 and 2016.
Does the first part of this comparison sound familiar?
NP has been replaced by the board for undocumented reasons. It is clear that everybody with CYDY has been directed to go silent. This helps control the shorts and shows everybody, especially the FDA, that CYDY is serious about its business. CYDY will hire an Ed Kaye type of CEO who has credibility with the FDA. CYDY is also getting the NASH, HIV BLA and Brazil results in shape to gain an approval.
Leronlimab is a seriously better new drug candidate than Etiplirsen was. LL studies are now designed to show that it is effective. Once these pending LL studies are polished and then presented to the FDA in a politically correct fashion by the new CEO, then CYDY will receive an approval. That is how SRPT played it and that is how CYDY is currently playing it.
The recent FDA letter of Feb means nothing. It'll only accentuate the political progress that CYDY has made when it receives LL approval
Don't expect to hear anything from CYDY until a new CEO has been hired.
Talk of a partnership or buy out will not get serious until CYDY has an approval. Big Pharma may be a pack of vicious, mean, bullying thugs but they are not stupid.
You can watch this story unfold, like it has for other biotechs, or you can pick up some more mighty inexpensive shares of CYDY now.
These are very frustrating but exciting times for CYDY longs. CYDY is now following a script that will work because LL works and because it is pretty obvious that the board and their "new friends" at SA have chartered out a known track to be successful, both scientifically and politically.
So don't get pissy because CYDY has gone silent. They have gone silent for some very good reasons. They'll talk when it is right and it will be different than before.
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