RE:RE:RE:Before the End of the Month???Good question, Midas. I can only speculate that in making this request that the FDA has and will do the following:
1. They have already reviewed the outcomes of the Brazil testing ...positively.
2. Whatever additional info was asked for in September has, again, already been reviewed.
3. They already have an expectation for the current testing, based on this most recent request.
As a consequence the outcomes of this testing will either meet or fail to meet these expectations. It won't take long at all for these to be assessed when you already know the expectation. Presuming that at this stage THRM management and partners have jumped through all the hoops, rendering a judgement on approval should take no time at all.
Cheers and GLTY!!!
1518midas wrote: The FDA would take some time to process the new informatiom and make their decision?