good points gestalt. wish i saw things as clearly in real time as i do in retrospect, that's for sure.
To me, the FDA is a typical govt agency - no different than the compliance group at my firm. generally reactionary, risk averse (although there are exceptions) and certainly flawed. And, for sure they have had conflicts of interest over time. but there are some good people there too - as i've had experience with another company i'm invested in who gained approval recently. Their coverage guy was slow, actually lost one of the filings they sent him, etc. - but honest and a good guy.
I have no idea if the dream-catcher thing was real or made up - who knows? But, what i do know is that Nader inflicted some very serious wounds on the reputation of this company. those weekly promotional videos with the famous one where he held up 3 fingers and said we'd have a triple digit stock price - i watched that and cringed. I'm in the securities business - that's grounds for getting fired.
But the real killer in my book was the partnership with Vyera - Martin Shrekeli's company. That guy is one of the biggest crooks not only in healthcare - but across all industry, to the point that there is a Netflix documentary on what a legendary scam artist and criminal the guy is.
So while i'm no fan of the FDA (to the contrary, i think they are deeply flawed), we have simply shot ourselves in the foot with regard to our credibility more than once - and any govt regulatory agency is going to hone in on that kind of thing.
Hopefully Jay can navigate us into the right path here - I think he's a solid and honest guy.
To me, the FDA is a typical govt agency - no different than the compliance group at my firm. generally reactionary, risk averse (although there are exceptions) and certainly flawed. And, for sure they have had conflicts of interest over time. but there are some good people there too - as i've had experience with another company i'm invested in who gained approval recently. Their coverage guy was slow, actually lost one of the filings they sent him, etc. - but honest and a good guy.
I have no idea if the dream-catcher thing was real or made up - who knows? But, what i do know is that Nader inflicted some very serious wounds on the reputation of this company. those weekly promotional videos with the famous one where he held up 3 fingers and said we'd have a triple digit stock price - i watched that and cringed. I'm in the securities business - that's grounds for getting fired.
But the real killer in my book was the partnership with Vyera - Martin Shrekeli's company. That guy is one of the biggest crooks not only in healthcare - but across all industry, to the point that there is a Netflix documentary on what a legendary scam artist and criminal the guy is.
So while i'm no fan of the FDA (to the contrary, i think they are deeply flawed), we have simply shot ourselves in the foot with regard to our credibility more than once - and any govt regulatory agency is going to hone in on that kind of thing.
Hopefully Jay can navigate us into the right path here - I think he's a solid and honest guy.
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