Good question.
To me, the trial to provide the evidence of the superiority of the product is the key. High level evidence from a formal high level trial that includes high numbers of participants is what is needed.
Not familiar with the processes in the USA, my experience with health research here tells me that the process for ethical approval can be very drawn out (and take much longer than anyone imagines).
Some of us believed that there would be announcement reporting the trial progress in Q1 2024 and now we are 2 weeks away from entering Q3. The details of the sample size, expected recruitment timeframe and follow up details are not known.....so with none of these variables public knowledge, there is no way of knowing when the product will achieve the progress to be commercially available.
Yes, other achievements will have an impact on the SP, however, to me the primary driver will be the valve able to be sold freely.
Just my $2.00 (2 cents pre consolidation) worth.
Good question.To me, the trial to provide the evidence of the...
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