Felling a little bad today? I never said never, just that BDD isn't likely to be a factor. Submission will definitely not be before May, but who knows after that.
The things that are out there that I am a little worried about are
- shelf life: is this required to be completed before IDE submission? is there a required shelf-life? if so what is it?
- root cause analysis on sterilization procedure: is there something 'wrong' with sterilization testing that has to be resolved before IDE submission?
FYI, I fed the idiot the ammo about the root cause well before the idiot started waving it around in his posts. I took heat for mentioning it from the cheerleaders on the board, but I don't care. Anyone wanting to consider all possible issues should be aware that 'root cause' is a very particular phrase that as far as I am aware is reserved for failure analysis. But it could be a 'better' sterilization process that we can choose to move to or not. Or maybe its only an issue if we are storing the gel long-term and is not relevant if the gel is made just prior to use. We simply don't have enough information about that brief comment in their Jan update to freak out about it. But noting it and asking for more information is fair game.
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