IRB should be sufficient for either cosmetic or initial
IRB should be sufficient for either cosmetic or initial steps for clinical testing for a drug product. I'm not saying the German Health Authority (their FDA) will not push for a separate one... but if they have international regulatory advisers who have any balls at all then they could argue their way out of doing those steps. (I know this because I have a background in international compliance and regulatory for a biopharma, and I also know first hand you can push back on regulations if they cause an undue hardship to the company and can be addressed through other verifiable means... but you have to know your stuff and you have to have the right attitude to do it).
On another note our FDA is terribly slow and costly... I'll leave it to MedIq the experts to say how long it will take to get a product to market but lets be honest here... has anyone confirmed this? I've reached out to MedIq and got nothing back. Also I think it's important to note that I would suspect that anyone with MedIq would be gagged from speaking about this with anyone outside of a need to know. My second point is that perhaps there was a response and this guy just pulled numbers out of thin air... we don't know. Who knows... if there was a response then it could have been that the product will be on shelves next week and people wanted cheap shares.
My point is that even it it dipped it was nearly silly to sell on someone else comments that didn't come from the company themselves or the vendor. Anyone can write a reply email and paste it into one of these chat windows. I'm not saying it's a lie either. I'm just saying we don't know. But it would make sense that David Furst would be gagged from talking to anyone outside of a need to know. And even though the history of the coming doesn't span decades they are not inexperienced so I would think they would understand this.
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