TS03 Inc Trust Units TSTIF

RE:Word Games

[echo2]

Lematou, I think your analysis is right on: while the pr states "similar" claims are sought with the FDA, given that claims regarding the Q180V were not part of the original submission package to the FDA and, while submitted weeks later I think, I recall mention was made only to discussions with the FDA regarding these claims for the Q180V. These endoscope claims are laden with medical-legal issues that will undoubtedly have the FDA consider them quite separately, but with no less diligence, from the other complex scopes including colonoscopes. But, this is in no way to downplay the critical importance of terminal sterilzation for these other scopes: there are significant infection problems across the board, but many of these latter have not yet received much press, let alone monitoring and definition of the true extent of the problems, and CDC and FDA interest, that the MRE bacteria problems have garnered. Hence, again, the reference to the 'seriousness' of the new standard of care issues confronting the FDA is not a word game, per se, but TSO3 must be very careful in their wording as they aim to maintain a healthy positive relationship of mutual confidence with the FDA.
Patience, especially with the FDA, is needed. 
The sky remains very clear and blue.
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