They need to increase their revenues and.or reduce costs of goods sold, and scale back SG&A. They might slightly "beat" this quarter because the USD continues on a slight upswing against other major currencies.
Management is significantly overpaid. I suspect they may prefer bankruptcy to slashing SG&A. They will likely declare bankruptcy within 2 quarters if they again post a 40m loss.
The CEO does have a significant holding of 281,000 shares, but he is already down 450k and his regular salary is 679K, so he does not have much to lose by declaring bankruptcy versus heavily slashing salaries and costs.
So the thing I was referring to is,
"(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA..."
I think that will override the other parts you cited because there is not going to be a "change in the safety or effectiveness of the device", even if a different facility or establishment is used -- the same workers and engineers would be designing and working at the factory, so there would be no change of experience or of procedure, especially if they simply rebuild the original factory just as it was before. If the smaller factory is used, things might get hairy, but presumably the same methods are used and the same engineers will design that section for the smaller factory.
This is why it seemed to me from the FDA's emails back to me that the FDA doesn't require a PMA supplement: a PMA supplement is required only if the safety or efficacy of the product changes. *If* they are going to make basically the same product in the same way, they will not need a PMA supplement.
It is just going up with small cap biotech and covering for under-performance after its April and September drops. Low 30s might be coming here and there will probably be a lot of volatility once it nears that resistance area.
According to te_st, it's ocrelizumab from Genentech (Roche). The station never answered my email.
1) RS won't crush the stock. Bankruptcy will. Get it right.
2) There won't be a lawsuit because it will go bankrupt earlier.
3) Just one "c" in "bankruptcy".
The FDA is probably the most efficient agency in the government.
The management is incompetent. I don't understand how people hope that FDA news will save this company.
Oh well.... someone kept selling it off by 3-5 cents as soon as it hit $4.20 for hours and probably covered at 3:00PM. Happy Thanksgiving everyone...
*goes into hibernation mode till Friday*