Fair and reasonable comments. Just one “nit picking” point. This is much more Med Tech than Bio and therefore had an easier path to approval and is less risky.
The critical component, adapt treated Bovine pericardium, is already FDA approved, proven over 10 years and in more than 20,000 paediatric patients (much more susceptible to calcium build up with rapid growth.)
Our Adapt tissue products continue to be sold by LeMaitre Vascular (Nadq LMAT) adding to our already unparalleled data set.
The majors know this and so yes we need more data for approval but the majors already know what we have and the risks of failure and non approval at this point in time are minimal.
However, as you say there is a big valuation gap that needs filling but future news flow like Nasdaq listing, FDA trial approval, Breakthrough Device status, more patient data, imminent 6 month Georgia patient update, first patients in CE mark European trial etc etc will all serve to fill in some of this gap before any “genuine” offers can be considered.
So I think you are on the right track, it’s just a matter of more data, increased MC and time.
But make no mistake, the majors know what we have and how valuable it is. This is not a drug and it has been proven to work. We just need time.
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