Do we have a large seller? Perhaps somebody feels a less than desirable outcome with the FDA will have a pronounced impact on the stock? I've already lowered my expectations. Any positive news out of the FDA meeting will be a pleasant surprise for me.
Good for MDXG to secure a meeting with FDA a couple of days before earnings release. Worst case, If the FDA meeting goes really bad, I'd expect a press release from management asap indicating the removal of injectables to usurp any further allegations. We can price that in and await potential good news from release (3 MACs) for a nice leg up.
The injectables are a bonus short term and the next phase for growth 5-10 years out (expect MDXG to be bought out). Amniofix is being treated like PRP with payers as "investigational" until more data is provided.
So, if the FDA says sell your product with close scrutiny and clinical trials. Does that affect the sales in US? Their products will be sold world wide. This is a huge new revenue stream not factored into guidance. Amniofix was only 15% of next year in US. FDA would not inhibit world sales of Amniofix.