Mr Simes,
I was pleasantly surprised to hear a response to my questions directly from the CEO.....
If i may, just a little history here , I was a stockholder in Cell Genesys for a couple of year and have been a SH in Biosante since CEGE was acquired a few years back. I own a manage my own Co, a small manufacturing/ distribution Co I have a considerable investment in Bpax along with some others that i had introduced Biosante to as a investment opportunity for themselves as well......Let me just say this, I am fully aware of the risk / reward involved in investing. Bpax portfolio stood out, more so , Some very impressive resumes of BOD and Management team with vast experience and knowledge in your field !
Can you please provide a explanation as to why a decision was made not release final safety data "prior to the merger with ANI " ? Withholding safety results prior to entering into a agreement to merge with ANI obviously would exclude the value of such a catalyst in the evaluation process , therefore adding to our value... Along with possible CV benefits.
Please note that we did release the results of the independent Data Monitoring Committee’s ninth review of the unblinded data from the LibiGel safety study on September 4, 2012. Unfortunately in spite of the positive report the reaction on Wall Street was less than enthusiastic, probably in view of the previously announced efficacy data. Since the FDA requires both efficacy and safety data and it should be clear we would need to repeat Phase III efficacy trials which as you rightly point out will cost approximately $35 million there was little positive reaction to the safety data reported to date. It is our assessment that a final safety report would not add materially to that reaction.
I realize existing Bpax SH maybe entitled to CVR's , up to 40 Mil ?
For clarity, BioSante stockholders will get 66 percent of any and all income due to LibiGel up to $40 million. However, please remember that after the merger BioSante stockholders will own approximately 47 percent of the merged company. Therefore in addition to the 66 percent split, BioSante stockholders will be the beneficiaries of 47 percent of the remaining 34 percent. In summary, in reality BioSante stockholders will receive the benefit of approximately 82 percent of the initial LibiGel income. After the $40 million is reached, BioSante stockholders will still participate on approximately 47 percent of any further income.
Assuming if the merger goes through, we the existing SH poss go through another RS , resulting in passing our share over to to ANI.....[ dilution ]
Please note that there is no additional dilution to BioSante stockholders due to the potential reverse split. BioSante stockholders will own approximately 47 percent of the combined company AFTER the reverse split.
The new combined Co then may, may not invest on new efficacy trials. [ unless of course use P&G effiacy results under 505 a ?] spend 30-36 mil to complete the two trials and then release final safety results ? On the surface i am sure you can understand how this just does not seam right. As a concerned shareholder, i would very much appreciate some explanation as to how this decision is in the best interest of Biosantes shareholders.
You are quite correct that the merged company could decide not to conduct the required efficacy trials and may choose to license out or sell LibiGel to another company more able to fund the trials. That is where the CVRs come in.
This is a question i have heard, and have asked myself,
"If we are sitting on a successful safety study, why not release the news.....PPS should see very positive results. Then do a offering to raise 40 mil for two new efficacy trials" ? Or partner with large Pharm.
Happily the safety data to date suggest the LibiGel is safe for women in the doses used in the safety study. However our board determined that the merger with ANI was a lower risk alternative for our stockholders to realize value in the near-term than funding new LibiGel efficacy trials at this time especially given the depressed value of our stock due to the announcement of the efficacy data back in December 2011.
I respectfully request some clarification.
Regards,
AI
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