Biogen had a straight forward study, a straight forward presentation and has been around the block. They have a track record of good science and not giving the FDA a hard time. In fact the FDA has never had to address a targeted Qanon style harassment campaign from Biogen investors.
Now I am no scientist, nor have I ever claimed to be a doctor, or even someone with extensive medical ties. But I do know what the scientific method looks like, what a properly controlled and recorded experiment should look like.
So if a layperson like myself applying some critical thinking can see CYDYs study is flawed, it's data presentation is flawed, and that a group of terroristic investors are harassing the FDA, it's not hard for me to say CYDY has a problem.
Here are CYDY's Irrefutable Problems:
1. CEO has overdrawn on his credibility and that overshadows the company.
2. Poorly crafted studies designed to shotgun for a P value rather than aiming for specific results in specific groups to drive P values.
3. Obscenely naked data mining. Taking results from it's shotgun style studies to claim specific results for specific groups. The only explanation for such hackery is the CEO and company want a good result, not good science.
4. Scott "Sports Medicine" Kelly talking around the actual science and what the results show. You can't keep talking about anecdotal evidence when empirical evidence contradicts you at every turn. Either your assumptions are completely wrong or you need admit your approach was flawed and retest. He needs to go too.
5. Time and Money. CYDY has neither to spare. On the time side of the equation vaccines and other therapies are galloping ahead of the company. Money side things are much, much worse. First there is no revenue. Not even proof of sales orders. Then there is the mounting debt. CYDY sold off shares to a debtor to stay afloat in the midst of a proxy battle.
Let me emphasis that move CYDY SOLD OFF SHARES IN A PROXY FIGHT.
Someone claimed it was new shares created to pay a debt creating a dilution. But the filings never actually said that. Even if it did, it only made shares on the open market cheaper to acquire for more voting power. Again though I want to point out the filings said the company used shares to pay off a debt, with no mention of actually creating new shares for just that purpose.
So CYDY is in a lot of trouble. It needs key personnel to be replaced and better study management and design.
So yeah the FDA was right, CYDY was wrong.
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