DJW spent years dropping by APRI to dump bs... I'm here telling you the truth.
Sorry for your losses. But your anger should be directed at the used car selling CEO who failed to manage what by all reason was an easy and safe drug to move thru if he had actually done the work.
Joe, is on the record that it would take at least a year to appropriately design a new phase 3 working with the FDA and at the present they have not indicated any intention to do so. Hold on to your hat... Enclomiphene not a phase 3 drug.
APRI, (Fispemifene) will announce results from the appropriately designed phase 2 in Q1 2016... That's about 60 days from now or less.
APRI, will be able to immediately work hand in hand with the FDA from those phase 2 results on trial design and target endpoints for their phase 3. They could be in phase 3 with guided design by 2nd half 2016. That's years ahead of Enclomophine. That's the reality.
Wrong... Chronic Prostatitus, ED, and LUTS are identifiable conditions accepted by the FDA with "un-met" need.
Joe, the fearless leader of RPRX banked on convincing the FDA that Low T by itself merited consideration as a clinical target for consideration without a substantive clinical underlying disease. Therefore the clinical work failed to "target a patient population" that was understandable, and then they went on to kick dirt on the methodology and conclusions.
Don't believe me? Go read...
APRI will move Fispemifene as they prove it addresses true and understandable "un-met" need.
Ya know the really sad part for RPRX investors? Enclomiphene could have done the same thing but Joe the used car salesman failed you in working with the FDA in clinical design. He wanted to make a splash by gaining market approval for a drug he intended to say hey if your fat and can't get off the couch take this for a testosterone energy boost and you will lose weight. The FDA shut that down... PERIOD!!!
With APRI there is a clear FDA guided approach focused on:
Multi-indication potential to treat symptoms related to secondary hypogonadism (low testosterone/low T), chronic prostatitis and lower urinary tract symptoms LUTS.
With RPRX, you had Joe's seat of the pants approach trying to used car salesman the FDA about weight loss in obese dudes. NO CLEAR TARGET OF A DISEASE!!!
“Therapy with fispemifene is not considered to be testosterone replacement therapy. Therefore, pharmacokinetic endpoints such as total testosterone could not serve as the primary basis for approval for fispemifene. Instead, clinical benefit for a specific disease condition would need to be demonstrated using clinical endpoints. The specific clinical benefit demonstrated in a clear target population would ultimately need to outweigh the risks in that population.”
APRI is going to be successful. They will be adding the indication of LUTS as a second indication to go with ED as a result of hypogonadism. That's what the FDA wants. They did not want to hear about helping fat dudes lose weight. Joe was an idiot trying to slide his idea of a weighti loss drug by the FDA.
APRI now in great position to grab the Low-T market with Fispemifene... Thanks Joe. :)
Shut up!!!! You are a fool being laughed at by everyone here and on the RPRX board.
You and your countless self proclaimed insightful posts of RPRX going to $60 this year. Hahahaha. Go jump off a cliff just like your stock.
Yep... And that's why Denner went into APRI so heavy.
Made a fool of yourself on RPRX now just an angry basher on APRI...
I read the posts on RPRX... Ouchh!!! Those people are really making fun of you.
Go back to your RPRX and GALE boards...
Congrats on your GALE at $5 and your RPRX in the $2s...
Fispemifene will be first to market.
One additional observation on the PPS... I believe sellers are betting, and they might be right, that Pascoe has failed in his financing objectives and as such we are days or weeks away from an announcement of very unfriendly to shareholder terms to raise cash.
I suspect the sellers anticipate the raise at current levels and to include warrants and no restrictions on short selling.... I also expect as you seem to that there is no financial relief coming from our retired pipeline like Femprox. All this in the face of failing to raise via Aspire at much higher prices warrant free.
Pascoe is a terrible executive and it is not out of the question that these things come to pass as his track record for destroying shareholder value while he swings for homeruns over base hits is well documented.
RayVa communication has not materially changed. Barbara T. from the latest CC on RayVa status.
"Preparatory activities with study design, end point confirmation, formulation development and investigator and CRO selection are underway to allow for startup in the second half of 2016. As part of this process we plan to seek regulatory input into the next phase of clinical activities including whether this indication and patient population might qualify for orphan status."
Important to note, IMO, the primary driver of the PPS is not the pipeline candidates status, RayVa, Fispemifene and now Vitaros US, each have very acceptable return reward for their investment risk and there are many bios with pipelines far weaker than the Apricus lineup.
The issue in front of the company for months now is financing. Plain and simple Pascoe has allowed fear in the company to grow and grow by failing to either line up a plan for financing the development of the pipeline or failure to share that information with the street.