Bagel, if everything falls into place as planned by Ani's Management. Corticotropin should be approved somewhere near Q4 2018 or Q1 2019.
As for a Libigel partnership announcement, it may be linked to the patent applications. I have no doubt Libigel has been reassigned at least partially, if not entirely. If AbbVie were not entertaining a buyout, it would have been announced a while ago.
Assuming the trial was complete August 2016, and there is enough data to support an NDA submission. It would take time to analyze all the data and get it ready for the NDA submission. They also have to get the peer reviewed documentation submitted. Case in point the AHJ article regarding Libigel took five months from submission to publication on-line.
The following is just theory but assuming it is AbbVie, they could not guarantee how the courts would rule regarding Humira patent protection. If it had gone in Amgen's favor investor confidence in AbbVie would have tanked. The Libigel story may have been rush out to stop the bleeding. Now they can continue as planned. Amgen would have had to give Abbvie 180 days notice prior to launching. Abbvie could have countered by submitting the Priority Review voucher as a defensive tactic which gets an FDA decision on Libigel within 6 month (Note: PRV must be submitted at least 90 days prior to NDA submission). This would help AbbVie change the Humira story.
Consider the following:
-Keeping quiet about the CV related discovery (Confidential agreement in place)
-The merger between ANIP and BPAX consolidated the majority ownership to vote along the BOD's recommendations. (Prevents BPAX need to break the confidentially agreement or heavily dilute to stay afloat)
- Abbvie was going to need a hormonal manufacturing plant, Ani Baudette plants fill that requirement.
- Dr Snabes gets hired by Abbvie (continue with trial)
- 2015 discovery that Libigel reduced breast cancer events
Post August 2016 ( completion of 5 year follow up)
-Libigel is no longer being marketed as a licensing opportunity.
-Libigel Trademark has been allowed to expire without ANIP submitting a replacement name(it takes time to get a name approved)
-Three new patent applications replacing the original.
- New patent application withholds breast cancer supportive information.
It certainly looks like a well orchestrated plan dating back to 2012, if not sooner. Personally, I think we are getting close to announcement. But the Humira pressure is off, at least for now.
JMHO
