Well I'm not immune to FDA rejection. I mentioned before that the FDA rejected a 510k application for a company I invest in, which seemed contrary to previous advice. But the company took it on the chin and raised funds to do a new trial following the FDA recommendations. Which is what you have to do if you want approval. If you decide not to follow what the FDA says you should then your chances of success are diminished. Note to SI and Dr Kurtzberg ..
CEO Itescu needs to go, page-137
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