RE:For all but the 28 tapped out retail holders…Agreed Gorf,
For anyone who does not understand the implications know this. Having a breakthrough device is far more than a mere title. It gives Spectral Access to rapid responses from the FDA (bi monthly check-ins) along with the ability to initiate Sprint discussions for rapid trouble shooting and guidance from their FDA investigator and also guidance on data through their Data Development Plan. I would argue that given their TIGRIS results currently exceeding expectations, the potential for earl efficacy stoppage at interim enrollment (90 patients) is high. Let hope enrollment increases ( and possibly more sites added to the study)
PM