Boston
Where to begin with your post...LOL
It's the FDA. I'll say it again. It is the FDA. Again. It is the U.S. Food and Drug Administration.
Yes clinical research is global; however, and once again, it is the FDA. The FDA has very specific guidelines, policies, draft guidance, CFR's and often times contrite arbitrary narrow opinions not based on any of the previous. Why, it's the FDA.
Amedica managment chose to conduct an OUS study to save money as well as expedite the time to market. Foreign studies can be inniciated much quicker. But now we sit here stuck in low gear, delayed over a year, and SNAP could very well face the same fate as CASCADE. Will that happen, very doubtful, but any who thinks FDA approval is a sure thing, are morons.
As for our Chief Executive, Dr. Bal, with all his wit, wisdom and bed side manor ultimately the buck and successes and failures lye with him. A decision was made to save money on the front end with an OUS Study, that decision is now costing the company and it's investors millions by what turned out to be a very bad decision. For all intensive purposes CASCADE and SiN4 were and are a massive success, but being best doesn't always win with the FDA.
To his credit, Dr. Bal's has done a very good job reducing the debt load and overhead expenditures. However, my experience and common thread with very successful start ups and early stage co's, and I've been directly involved with a few, is managment and BOD takes next to nothing as salary and instead focuses all economic resources to getting the products to market. What's more important, executives taking a few million in salaries in the front end and skimping on product development, or eating top ramen for a couple years so that your revolutionary disruptive tech takes the lions share of the market?
It's a simple business model that doesn't take an Ivy League Grad to figure. I personally intend to participate on Thursdays call but I have doubts the company will allow it.
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