I am a board certified urologist. See my prior posts on SPPI. I agree with a lot of the negative posts concerning the crowded testosterone market but I want to share my thoughts for those longs. I was already invested when the libigel data for efficacy came out. Despite all the naysayers I bought more when it went down. Why? I was fairly certain that its testosterone gel would get approved. When it did I sold half my shares somewhere north of 1.00. I still have a large number of shares, somewhere over 25,000. I personally will not sell at this level and I do not believe libigel is dead. What do you think would be worse? That it was highly effective with great sexual efficacy but very poor safety data, or that it's safe but has not met its end point. I personally would take the later. If it's safe then some one will come up with another study to show some efficacy. Will it be another company? Possibly but BVAX will not give it away for free. Will it take a year more? Possibly. BUT SAFETY is the key. Because it's safe then its just a matter of another study to show its usefulness. Those that tear it apart and say it has no value are not in my opinion giving any credit to what in my opinion is obvious. I would have been out of this stock totally at over a 1.00 if the safety profile was bad but the efficacy was good. The latter would never get approved the former in my opinion eventually will. There are obviously many shorts on this board. DO your own DD. Hope this helps give some balance to why longs may want to hold and not sell at these levels. Would I buy at this level? Not unless I was covering a short position. Shorts will eventually need to cover as I personally think eventual good news about libigel will drive it from these levels. I agree with most of what's written about the testosterone gel. That's a big market to crack. But libigel is a different story.
That's what I was trying to research last night. What would some alternative treatments be based on the initial results.
Simes and crew know the product is safe, probably have to initiate another trial to test results specifically for CVs. And then they can submit the NDA -
What I did find out is CV causes 17 million deaths in women a year and increasing. CVD is the number cause of death in women in the US.
Another route is if this product does improve CV events, then think about all the products out there that have a negative effect on CV. Could L be release as a supporting product?
Prob explains the recent patent applications submitted for libigel lowering risk of CV ?
Rem when PFE stumbled on V its intent wwas for something other than what its used for today !! If libigel is proven to lower the risks of CV and have other benifits , The market potential will be far greater than just a female V , Potential overall health benefits ??? yes
HERE ARE THE PROBLEMS. Ok, if they do bring the LIBIGEL back...
How long is it going to take?
How much more is it going to cost the company?
What is going to hold up your current price until that actually happens?
Are you willing to risk your own hard earned money FOR THAT LONG for just a hypothetical scenario?
What if you are wrong?
Are you willing to risk all your money based on your what if scenarios?
Even if it gets approved, will the hype will be still there knowing that this was once failed drug?
I guess if you are willing to take all these risks for a small reward, please be my guest and hold on to your shares...lol
You guys are missing the whole point.
There are millions of OFF-LABEL testosterone prescriptions currently being given by doctors to address FSD!!! The FDA wants to solve this problem!!!
LibiGel will be the first of it's kind for this treatment that will not only complete a Safety Trail under an FDA SPA but, as it turns out, LibiGel is actually REDUCING the number of CV events vs placebo.
The FDA will aprove LibiGel to treat FSD for the following reasons REGARDLESS of efficacy:
1) LibiGel will have completed a safety trial under an FDA SPA.
2) LibiGel will address the off-label usage issue.
3) LibiGel REDUCES CV events.
This is a win-win-win for all: the FDA, Doctor's and patients.
Get it through your fat heads bashers/shorts, like it or not LibiGel will proceed, an NDA will be submitted to the FDA, and it will be approved.
We have found a bottom here around 77 cents. I did the same sold half my shares before the run up 2 weeks ago the first time when it got over the $1 hump. The trend is upward, the whole reason for the drop from $2.50 is the Libigel failed attempted at approval, but that is overwith and they are continuing their efforts going forward to approve it now.
I beg to disagree with you because pharmacies compound testosterone all of the time for females to use and the patients say it works. Now BPAX has to get qualified people to gather and present the data in a way that will allow it to be approbed. JMHO
Most investors probably have no clue ! Safety is key and it's looking 90% plus chance of meeting it's primary endpoint ! We should get news around may of this year , the final safety from FDA , I have no doubt bpax will back into a FDA approval for libigel
Safety study takes several years , even if they have to do a new efficacy is takes 6 months what people fail to realize or acknowledge not only did libigel work , women that were menopausal had their level of Testostrone return to post menopausal levels!!!
There are no T gels on market for women with proven safety , FDA approved safety. Efficacy is subjective , libigel will be approved , It also appears to lower risk of CV and ??? Bpax has a few patents for libigel for same, if it does ,
This stock pps will be looked back on by many !
What kills me is, even in todays articles you see them say Libigel failed FDA approval, uh what? Pretty positive they haven't even filed NDA -
Safety is key, it may have not met it's endpoints but it wasn't a total failure either. It will be interesting which route they take for the NDA. There will be a NDA submitted, that is gauranteed and given the safety profile, what are the odds of approval for the a "designated" treatment?