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Re: NickHous post# 7927

Tuesday, 12/19/2017 8:05:08 AM

Tuesday, December 19, 2017 8:05:08 AM

Post# of 10345
...lets face it FDA...giving ARTH management "one day" to answer is = "we are rejecting, but the WHY (what were the questions) and HOW ARTH can overcome and satisfy FDA are still at issue...

...at least with SH.

With resubmission/review and decision at least another quarter or two away ...another issue/question rears it's ugly head.

Assuming approval ... What is the shelf life of product already manufactured? Management indicated it has "produced" product in anticipation of sales...but how much has been produced and how much will have to be destroyed and at what cost, if we get final approval 6 months from now?