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sharkey1

12/15/17 11:12 AM

#279618 RE: lasers #279617

From 2 cc's ago, last Aug.

All these five resulted in [two item 483] [ph] that have nothing to do with warning letter. The inspectors that went through all the attributes of the warning letter, told us that we have met our commitments. We have responded. All the responses are with FDA, and we just await their final decision. I believe it will be favorable. Obviously, the fact that they did not write us up on anything, will tell you it's going to be favorable. But FDA sometimes moves a little slow.

Will the warning letter hold up approval for our ANDA filings? Okay. We would definitely need the warning letter resolved before the approval starts to coming in.

soooo, I see the pade getting resolved at the same time of the approvals, perk and narco, and if the God's are kind throw in a couple undisclosed,
and bring SequestOx back to the front burner

YJ4LIFE

01/26/18 4:43 PM

#282353 RE: lasers #279617

Lasers, miss your posts.