i think that's right. our "credibility" bank account was way overdrawn for years under NP / Amarex. As you said, we received very specific guidance from the FDA more than once - and yet continued to submit flawed and incomplete data via Amarex. Add to that Nader's way over the top promotional approach, 3-finger / 3 figure stock predictions, and the partnership with Martin Shkreli, and it's easy to see why we were viewed as a problem child by the FDA.
before going on leave, Cyrus was doing exactly what needed to be done, and had turned this around almost totally - and was a long way down the path of restoring our credibility - he knew how important this was, as he even planned to change the name of the company after getting the hold lifted to get rid of the stigma. While i was incredibly disappointed, in thinking about it further, i'm not totally surprised that the FDA pushed the hold out further - again, multiple years of bad behavior, and 1 year of doing things right - they're still gun shy with us. But i feel like we were right there - and then Cyrus goes on leave. just really bad luck.
so, as you said, here we are. so critical to get this CEO hire right - someone who can continue to repair things with the FDA, bring business connections, etc. and while some have speculated that deals are being signed, holds lifted, etc. in the the background right now, i just don't buy it. just like life in general, we have to create the catalyst ourselves - finding the right CEO, getting the hold lifted, and finding a partner. if we can get some wins (even small incremental wins like those) the sky will begin to clear for us, and the SP will follow.
before going on leave, Cyrus was doing exactly what needed to be done, and had turned this around almost totally - and was a long way down the path of restoring our credibility - he knew how important this was, as he even planned to change the name of the company after getting the hold lifted to get rid of the stigma. While i was incredibly disappointed, in thinking about it further, i'm not totally surprised that the FDA pushed the hold out further - again, multiple years of bad behavior, and 1 year of doing things right - they're still gun shy with us. But i feel like we were right there - and then Cyrus goes on leave. just really bad luck.
so, as you said, here we are. so critical to get this CEO hire right - someone who can continue to repair things with the FDA, bring business connections, etc. and while some have speculated that deals are being signed, holds lifted, etc. in the the background right now, i just don't buy it. just like life in general, we have to create the catalyst ourselves - finding the right CEO, getting the hold lifted, and finding a partner. if we can get some wins (even small incremental wins like those) the sky will begin to clear for us, and the SP will follow.
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