Why would they back down? An inspector did their inspection, made observations, and had question in their mind if this process fits the rule of minimal manipulation. If they question the process, definition fit, then they are probably doing their job to report that. I'm not sure that inspector is the final say of the whole FDA and that is probably where SVFC is going to make its explanation and response. Could it also be a competitor questions the claims of the company and its process to prompt this? The only thing that matters now is the response and outcome. I have not seen one yet.
You may be right but reading the web site, I can't see where they are altered? I am no doctor but taking fat tissue, harvesting stem cells and reintroducing that same population of cells into an injury area does not seem to fit the bill as altered or becoming a drug.
Where do you read drug in this? If they are manipulating your own cells? I would be more inclined to believe Cytori is more motivated to inquire the legalities as a direct competitor to this type of treatment?
Uh, where the FDA says it is a drug and doesn't meet the requirements of minimally manipulative.
This 'company' will have zero revenue for the next year...if they are lucky. What doctor in their right mind would purchase this machine and then inject an unproven, untested drug into a patient. There is no way their malpractice would cover it.
So, they can address their concerns to the FDAs letter. It doesn't make it go away. This will take years to resolve with legal fees and consultants. And who is going to fund this court fight against the FDA? This company has no money.
The liability they are already have is enormous. Everyday they do this procedure given the FDA's view that this is a drug only makes it worse.
Good night. Let's see what company purchases this shell next.