Surely this company has now got to go through the proper fda clinical trials process. The stuff works well and is safe. Why not prove it to fda standards?
With hindsight this is how it should have been done in the first place. I was surprised when the company said they could get it EU approved as a device. imho the EU are scared to approve it, as there isn't enough evidence to satisfy them.
There's $8m in the bank, so enough to get the trials moving. I would buy in if they started a proper clinical trial.
Best wishes to holders.
Cheers
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