GREY:TSTIF - Post by User
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Freedm40somthngon Jul 06, 2016 7:18am
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RE:Echelon: TOS, Top Pick: Target $6.25
RE:Echelon: TOS, Top Pick: Target $6.25 Excellent quote from D. Loe in Cantech link indicating the magnitude of FDA extended claims:
Loe says this news is evidence of why he has a Top Pick rating on TSO3, and says he thinks the recent run up in the company’s shares is a trend that is just beginning.
“After years of interaction with the US FDA that we could at best characterize as challenging, we are encouraged in the extreme to see the agency now hold TSO3’s VP4 platform in high regard, sufficiently high in fact that it has not just approved the device (back in FQ414) but has now differentiated it among its peers by granting specific claims to VP4 for sterilizing flexible multi-channel endoscopes,” says the analyst.”VP4’s conventional FDA approval certainly allowed for client hospitals to use the device for endoscope sterilization if they chose to, but new claims were based on endoscope-specific sterilization data that TSO3 submitted independent of its original 510(k) submission, data that by definition was sufficiently convincing to the FDA that it published specific claims on this capability.