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Re: Garden Rose post# 21857

Thursday, 01/12/2017 11:12:05 AM

Thursday, January 12, 2017 11:12:05 AM

Post# of 38634
Naturally only those involved can say for sure- but as Samsa and others have alluded to here- since they filed the NDA, and openly stated they are actively pursuing multiple manufacturer options we can assume (if the FDA acceptance is granted):

1) IPCI will need to announce the manufacturer shortly after (not sure how long exactly) the acceptance is received.

2) The letter should be received within the next approximately 30 days

3) IPCI COULD announce at any point... but appear to be holding off for something.

4) The manufacturer might not be the partner- but logic would strongly suggest they will be.

Therefore- I say we hear something in the next 30 days (or sooner) if the FDA grants acceptance letter.

Your results may vary...