The FDA will approve because the risk reward is too easy. Look at the risk: Numero uno, ALREADY APPROVED IN THE US (GEMS);;; Approved in Canada/Australia for ankle/fusion indication;;; Single application drug, no long term issues. Now look at the reward: Eliminates need for autologous bone transplant, a source of infection and healing issues and COST. Let me say that again.....REDUCES COST!!! That is one of the current FDA mantras. The FDA presented its worst case before the panel AND LOST!!! My bet is with the panel.
Now on to address the letter....
I find it odd that the letter has not been issued. Yet, assuming 1) the FDA is requiring more preclinical trial; 2) the FDA was specific in the July meeting (and in subsequent communications which I suspect there have been a few), I find it equally odd that there is no new augment clinical study.
The FDA has been blunt. "Preclinical" means before approval. These are quite specific.
"With regard to Discussion Question 3, the Panel was in general agreement that the statistical analysis was generally insufficient. The Panel has concerns about power, intent to treat analyses, and general design flaws."
"With regard to Discussion Question 6, the Panel generally believed that there is a need for additional preclinical and clinical testing for this product with regard to toxicology and teratogenic potential. The Panel felt that particular attention should be paid to pharmacokinetic analysis, antibody production, longevity and dose-response curves."
Yet the panel voted anyway in favor. And there are no new trials.
May be you should call and find out what the heck is taking so long to type a letter :-)
These are all publicly available info, not sure if correct.
Designated Federal Official (DFO) for Device Panel
Avena Russell, ABD, MS
Margaret McCabe-Janicki, Food and Drug Administration, Center for Devices and Radiological Health,
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area)
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.
FDA/Panel guidance has been sufficient to cause the company to change the injectable augment trial, increasing subjects to 300 to address statistical concerns. Yet nothing on augment? Looks like a hail mary, hoping for interim augment approval.