If you go to the SEC website, you can get a sneak peak into the headlines tomorrow..
"We had an end-of-Phase 2 meeting with the FDA on bremelanotide for FSD, and reached preliminary agreement on key aspects of Phase 3 pivotal registration studies, including FSD patient population, primary and key secondary efficacy endpoints, study design, doses election and safety monitoring. In addition, the FDA agreed that the Phase 2 data adequately characterized blood pressure and heart rate signals of bremelanotide, and that standardized methods for in-clinic assessment of blood pressure would be sufficient for Phase 3.Based upon the discussions with FDA, we intend to complete protocols for the pivotal Phase 3 studies, with patient screening scheduled to start later this year."
End-of-Phase 2 Meeting with FDA on Bremelanotide for FSD
In the end-of-Phase 2 meeting with FDA, Palatin reached preliminary agreement on key aspects of the Phase 3 pivotal registration studies, including:
FSD patient population
Primary and key secondary efficacy endpoints
In addition, the FDA agreed with Palatin's position that the blood pressure and heart rate signals of bremelanotide had been adequately characterized during the Phase 2 program. The FDA also agreed with the proposed Phase 3 blood pressure monitoring program, which will consist of standardized methods for in-clinic assessment of blood pressure.
"We view our positive meeting with the FDA as a major milestone in the development of bremelanotide for FSD. We are pleased to have concurrence from the FDA on the design and selection of efficacy endpoints of our Phase 3 clinical studies," stated Carl Spana, Ph.D., President and CEO of Palatin. "We are also pleased with the FDA's concurrence that the blood pressure monitoring program for our Phase 3 clinical studies only includes standardized methods for in-clinic assessment of blood pressure. We look forward to advancing bremelanotide for FSD towards a successful NDA filing and furthering our discussions with potential collaboration partners."
Based upon the discussions with FDA, Palatin intends to finalize the protocols for the pivotal Phase 3 clinical studies and start screening patients later this year.
I see absolutely no good news here. So they have had the FDA meeting and can go ahead with the Phase 3 studies. Why didn't they release this info sooner? I thought they said that they would do this as soon as it happened.
They also state that they do not have enough money to complete the study. No surprise here. Then they give the typical message about how they will have to raise money or get a collaborative agreement etc.
My own personal feeling is that if there were any kind of partnership in the works we would see more positive share price action.
I hate to say this but right now my expectations are lowered. Let them prove me wrong.
PS sorry if this message appears more than once. I've been having trouble getting it to post.
I think the 10-Q is generally positive. Palatin has to be careful with releasing information regarding the FDA. They haven't agreed to a P3 protocol yet: "Based upon the discussions with FDA, we intend to complete protocols for the pivotal Phase 3 studies,"
With regard to a partnership, I think they have one in the works otherwise they wouldn't be wasting money bringing second line MC4R peptides for ED and FSD online. If bremelanotide makes it to final commercialization, it has 5-7 years before the patent expires. Reading between the lines, I think the recent patent announcement is significant. A future partner will want exclusive intellectual property rights to melanocortin based peptides for sexual dysfunction which may last several decades.
I think on balance that it's positive because they have come to agreement with the FDA for P3 and have dodged the blood pressure issue with a drug that has been shown to be highly effective and fairly safe. This implies to me the company can warrant a $200M+ marketcap which will translate to about $1.50+ on a fully diluted basis.
Right now there don't seem to be any clinical road blocks. Financing should be available either through a stock offering or through partnership. QVT and BVF have too much money committed to cut out now when brem has a first mover advantage and great efficacy/safety data.