Deadline is Mar 1st: 60 day vs 74 day FDA response
Today I talked to pro's who actually work in this field. 60 day refers to the time period for FDA to complete its REVIEW of the NDA. 74 days refer to the time period for FDA to COMMUNICATE the review decision to the sponsor.
This means that ATRS will receive the FDA communication by Mar 1st, 2013; which is 74 days following their NDA submission. Of course, it can happen earlier but March 1st is the deadline.
Also, I noticed that the latest corporate presentation has a typo regarding the submission date of NDA. It says Dec12th; but, the PR clearly shows that it is Dec 17th.
Directly from Antares today: "Sent the NDA to the FDA on December 14th. The FDA confirmed receiving it on the 15th (Friday) late in the day. Antares put out their press release the next business day (12/17)." Consequently, the 12/14 submission date (the date is was shipped to the FDA) stated in the new investor presentation is correct.
The FDA date clock started on the 15th. The day the FDA receives it is the day they stamp it. That means were now at day 70. Next Tuesday will be day 74.
Most (the large majority of) NDAs are approved by day 60 - the FDA confirmed this. That said, the time of year the NDA was submitted didn't help Anatares' cause. Folks (even govenment employees) take vacation time the week before Christmas, the week of that holiday, and the week of New Years. Hence, like many other organizations, things slow down until the first full week after the New Years holiday. More than likely the timing of submission factored into not getting word as soon as hoped for from the FDA on the Otrexup NDA.
If ATRS confirmed that official submission took place on 14th then Feb 26th Tuesday is the deadline for communication. The investor presentation said it was 12th of Dec not 14th, so still a typo. Maybe they fixed to Dec 14th. Anyhow, that doesn't matter now. Although the deadline is 26th, we may have it today. What do you think. It would be good to put out the PR after hours, and SA guys, and Fool guys can write their articles over the weekend.
FDA will notify the sponsor whether NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of the completeness of NDA.
One more week and we will all know it. ATRS will go to $4 or $2.5, once the FDA communication is revealed. Not on the announcement day, but I expect a move starting on the announcement and follow through in increments for weeks to come.
It will go higher than that, is thing most of the share jugglibg is coming to a close. There is no daubt whatsoewer will accept the submission, they would have had to rejected the submission within 60 day's had they wanted to do so.