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Re: jmgotch post# 100045

Wednesday, 02/10/2010 8:21:18 AM

Wednesday, February 10, 2010 8:21:18 AM

Post# of 216278
The Dec 21 PR mentions 1) finalize end product design, 2) secure manufacturing contracts, 3)amend KFDA application.

Since KFDA application is deeply intertwined with the manufacturing process, I would be suprised if any are stateside until KFDA approval is granted. The KFDA process had been posted here in depth. Also, he said that expected timeframe was 6-8 weeks once the filing was updated. I figure that filing happened early to mid-January because of the holidays.

So, IMO the whole process is still on-going and the window may well stretch to the end of February. All just my conjecture, but I think we need to keep it realistic. Even Rain said that we should add more time to things.
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