Over those six years, VRPM had $200M revenue from Vanc each year, so it profited hansomely - regardless of FTC action, it came out quite well.
BMTI is not in that position. The AugmentMatrix approval (without review) was our consolation, imho.
Hard to say, the FDA wields such absolute power. going along may be best for a small company at their mercy. General Counsel Douglas may be right not to rock the boat.
Ex.- ViroPharma has been successful for over six years, holding off a generic against FDA actions, but that has now ended and the FDA may be vindictive in calling for a FTC investigation:
BMTI has nothing to loose challenging the FDA, imho. Some will say that's insane as the government holds all the cards and raising a legal case would only delay judgement and approval. I disagree as the altered guidelines are now a given and the company will continue the work to provide for them. A legal case is a separate item entirely and would add justifiable pressure to win approval. True, the company is small but whimps don't win.
Today, Mylan challenged the FDA and Sibelius with a law suit:
Yes it is a big risk anytime dealing with the FDA but that risk is fully priced into the stock. With BMTI trading around cash value with no value assigned to the technology or other assets I don't see the stock going below $2 the rest of this year. At $14 or $10 or $8 or even $5 it is a very risky stock but not in the $2's IMO.
BioMimetic is still seeking Food and Drug Administration approval for Augment, its flagship bone graft device. In January, the company cut its workforce by 25 percent amid a delay in its FDA approval process. In Tuesday's earnings release BioMimetic said it hopes to have a revised application before the FDA by midyear.