Tuesday, May 07, 2019 11:00:23 AM
1) MHTX was granted 510(K) approval over 10 years ago, meaning that the ECAP/SPD version of the titanium was not materially different than titanium, and that it could be marketed.
http://www.mhtx.com/news-and-media/press-releases/fda-approval-granted-on-new-titanium-dental-implant/
2) You're expecting Fort Wayne Metals to capture 10% of the world market for ALL globally produced prosthetics and orthotics. You're suggesting that at least 10% of the content of ALL prosthetics and orthotics produced globally is titanium, when in reality most contain NO titanium. On top of that, you're suggesting that of all those products, ultra fine grained titanium as produced by ECAP/SPD would be required.
Seeing as how exactly zero percent of the world's prosthetics and orthotics contain UFG titanium (other than an implant in Terry Lowe and a few eastern Europeans via Nanomet) maybe you should revise your assumption down a bit. Maybe, like...oh...I don't know, how about in the range of .05% if they're incredibly competent and lucky. How about .001%? That sounds more likely. I can tell you this much, Marv and Manny needed a win and were desperate to get a contract. My assumption based on long experience is that they lost the farm, but salvaged enough to post a hefty "Administrative Expense" on the next four or five 10Ks.
3) It's possible. That may even be a bit low. Hard to say.
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