I guess my rambling posts weren't very clear. Further clinical augment trials make no sense regardless of the letter. Injectable augment trials have already been changed in order to comply with the panel recommendations, the FDA meeting and subsequent FDA communications. The injectable augment trials will be completed before additional augment trials can be completed and will address FDA concerns because it's essentially the same product. Management is hoping for an interim approval of augment based two assumptions 1) that the FDA accepts safety and efficacy of injectable augment as a follow up; 2) that the FDA is lenient because augment is essentially the same as already approved product, GEMS. As of 9/30, the company had only 66 million in cash, burning 9 million per month. 45 million is in investments. So before the end of December, they need to start selling those investments or raise cash. In the past, they have raised cash rather than sell the bonds. Issuing more shares at 2.50 is not a good thing, obviously. The company needs some good news. Having approval in two markets in which the company does not anticipate significant revenue is not good enough. A very positive letter would do the trick.
They burn 8-9 million per quarter not month! They have almost 2 years worth of cash left provided they get that 10 million payment for the Europe GEM approval.
You are correct in that the injectable study will basically be the 'new study' that some wanted on the advisory panel and should do the trick for approval for Augment.
Below is a definition of the word "soon". Something the FDA obviously doesn't understand!
soon (sn) adv. soon·er, soon·est 1. In the near future; shortly. 2. Without hesitation; promptly: came as soon as possible. 3. Before the usual or appointed time; early. 4. With willingness; readily: I'd as soon leave right now. 5. Obsolete Immediately.