I was in it briefly with a very small position leading up to the FDA news, but sold out soon after. It was mainly as a small punt. I'm not really keen on building a position here, not yet at least. The tech is definitely there but the company and management is not. It is fine to mess up with a clinical trial or the FDA process once. These are quite small companies, not big pharma players with an army of regulatory consultants. It is very easy to make a small error, these processes are incredibly complex. But when a company continues over and over again to fail to comply with the directions of the FDA, that indicates poor management to me. The FDA literally spelt out exactly what they wanted and the company still failed to comply. It seems like now they may have finally gotten the message, so hopefully they can finally bring this tech to market after years of messing around. The frustrating thing is that it's not like the FDA came back and said that it doesn't work, the only reason they haven't gotten approvals and subsequent enormous revenue growth is because they don't play by the rules and so now patients and investors suffer.
Don't think I am going to have another punt here, but there is potentially a lucrative high risk high reward play here for non-existing investors given how depressed the price is due to the huge amount of pessimism. That is if management can actually follow the rules and deliver this time...
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