Jp20111, I think it will all make sense within the next year, most likely the next 6 months. I too would rather see ANIP take Libigel all the way, but their actions point towards a partner.
Since the breast cancer reduction discovery only surfaced in 2015, it is indicative of one of the following scenarios.
1- ANIP did the analysis of the pre-marketing part of the Libigel study and made the discovery. However, if this were the case the specifications and details supporting the claim would have been included in the patent application. It would serve no purpose and actually would be detrimental to advancing the patent application to purposely withhold the information, as the patent application presently stands.
2- ANIP did the pre-marketing analysis and continued the study thereby making the December 2015 discovery. The R&D expenses for ANIP do not support their continuing the trial to make this discovery. Once again if it was their discovery they would properly supported the claims. Since it was not done it is highly unlikely they made the discovery.
3- A silent partner such as AbbVie, did the pre-marketing analysis and made the discovery the breast cancer reduction discovery. However if the breast cancer discovery had materialized earlier we would have seen the claims added earlier. Otherwise, they risk someone else slipping in ahead of them and claiming prior art. Not a risk worth taking. Therefore it is likely that they also continued the safety/efficacy trial and made the discovery upon the continuation of the trial.
Now if the study was not continued, any future partner would have to start a large testosterone trial from scratch. The FDA is sill going to want 5 years of continuous use safety data. Not continuing the trials essentially wastes 7300 patient years of study. The 70% CV risk reduction discovery at 4000 patient years de-risk the continuation of the trial. Had BPAX publicly advertised these findings and were truly looking a for a partner they would have had many offers by large pharma to continue the trial.
The logical move was to continue the trial and have the partner take it the rest of the way. The fact that Dr Snabes worked for both AbbVie and Bisoante at the same time and was later hired full time by AbbVie, in addition to contracting IT work to Pat Fuller is consistent with a tech transfer of Libigel to AbbVie in order for Dr Snabes to continue the study.
Something to consider when Biosante completed their part of the study non of the patients would have had complete 4 years of follow up. By December 2015 the majority of patients would have completed the 5 years of follow up.
In 2013 Przybyl admitted that his eventual goal was to get a co-promotion deal for Libigel. The fact that no announcement of a partnership has been announced while evidence supports the existence of a partnership, is most likely a condition placed on them by the partner. This allowed the partner time to decide whether to acquire ANIP or partner on Libigel without ANIP attracting hostile take over action.
JMHO
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