IMO it is a trial and would require patient consent. The drug is not approved to market and that is Europe anyway, so you can’t charge for it. I don’t believe they are using an EAP there although ‘specials’ is essentially the same.
People do realize that an approved specials program means the regulator already believes the drug to be safe and effective, right? By regulation, right?
What is missing is manufacturing certification and a formal approval. Not much more than that. We know they already approved the new endpoints so do your own math…mine is saying January or February there too. Everything just seems to be coming together for some very big news to hit the market in Q12022.
FDA never provides public clarity and rarely gives full clarity to anyone in private. You can’t update a website without that clarity, and to do so while in process or while running a coming soon campaign give away a lot, especially since they chose to do the more hazy pathway.
I know there are still skeptics of ‘coming soon’. All I can say is that what keeps adding up in terms of marketing is not something that regulator would allow to continue even for companies a little bigger than 16 employees and pennies on the dollar of value. They may not lower the boom, but they would stop it. So even if it is turning a blind eye and not a 6 month window, a blind eye speaks volumes.
Don’t you think the helmet would and has formally complained about these activities? The world we live in is not a bubble.
