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Thursday, December 22, 2016 4:46:41 PM
I previously pointed to the fact that Abbvie bought the Priority Review Voucher (reduces FDA PDUFA review from 10 months to 6 months) for $350 million from United Therapeutics August 19, 2015, the day after Addyi was approved as the first drug to treat HSDD in premenopausal women.
Addyi approval
Abbvie Priority Review Voucher
No FDA approved drug presently exists to treat postmenopausal women for HSDD.
Given that the CVR's started showing up in trading accounts. I felt, as many of you, that it may be connected. That Abbvie was preparing itself to go after the postmenopausal market.
Remember that May 28, 2015 Sanofi obtained a Priority Review Voucher from Retrophin for $245 million. Sanofi paid $150 million, followed by two equal instalments of $47.5 million in 2016 and 2017. Abbvie on the other hand paid the $350 million in full, September 2015, as reported in United Therapeutics filings.
Sanofi Priority Review Voucher
We all know that Louis W. Sullivan, MD served as Biosante's Chairman of the Board from 1998 to June 2013 when they merged with ANi Pharmaceuticals. He led them throughout all of Libigel's development including the CV risk reduction discovery, through the Merger with Ani Pharmaceuticals a company that manufactures Hormones and has large capacity.
But I missed the fact that Dr Sullivan has been a member of United Therapeutics Board of Directors since 2002.
Sullivan Bio
Well played Dr Sullivan.
Especially when you factor in the follwoing:
- Halting of the trial,
- The merger with ANI Pharmaceuticals.
- Promoting Pat Fuller to VP IT, (Preapring Data and systems for transfer?)
- Dr Snabes being hired by Abbvie as Sr Medical Director of men and Women's Health
- Pat Fuller doing contract work for Abbvie. (Transferring Data to Abbvie?)
Now when you consider that December 19, 2015 Denton's (Patent Agent) prosecuting the patents applications added the Breast Cancer reduction claim, it proved the data was being evaluated. Upon review of the protocols of the trial from the AJH article it is evident that follow up examination of the 3656 patients including yearly biopsies was being conducted.
It is looking more an more like Abbvie and Dr Snabes was in control of the study the entire time since Biosante stopped their portion (January, 2013)
Only a matter of time.
JMHO
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