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H2R

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H2R

Re: markjohn62 post# 4344

Thursday, 04/05/2018 2:04:48 PM

Thursday, April 05, 2018 2:04:48 PM

Post# of 4817
Hi markjohn62,

I think it's good news overall for the Company, but the Class II may be what's causing a cooling off. Some investors may have anticipated a Class I category, hence an earlier action date by the FDA

See SmithOnStocks discussion on the matter:

Let’s assume that Antares makes the resubmission in June. In July, we will hear if the FDA accepts the filing as complete. If the review is classified as a class I (two month) review from the date when the NDA is resubmitted, the PDUFA date would be September of 2018. If the review is class II (six month review), the PDUFA date would be December of 2018. In my opinion, this should be a class I review, but in dealing with the FDA there is no certainty and the agency is overworked and missing deadline after deadline. Hence, I would bet money that this will be a class II review. This could lead to lead to a January 2019 launch.



Now:
1) SmithOnStocks was right about the Class II
2) He expected a date with a Class II in Dec. 2018 and it's for September 2018, so better for him.

The market may have been more optimistic about the action date.

As for me, I see it as very positive, but again, the Market does not follow my views; Go figure :))

Best of luck in your investments!