The 10q Today shows 6 Million left in cash. That is about 2 quarters of operating losses. This company may be in trouble. Without additional cash that is it for the new product development. They did not even get the full 500k and it is spread of 10 years. Will the company be operating in six months? Good luck with the stock offering - would any broker outside of FF take the deal- I wonder.
A consecutive group of 88 men with lifelong PE who decided for themselves to be seen for rapid ejaculation was studied. The age was 37 +/- 11 years (mean +/- SD), range 18-64 years. None of these men was ever treated for PE and 21% used medication that did not affect sexual performance. Of them, 71 (81%) preferred a drug for daily use, 14 (16%) a drug on demand, while three men preferred topical anesthetic cream. Those men who initially preferred daily treatment did not change their view after standard information about efficacy and side effects, while 9 of 17 men who initially preferred on-demand drug treatment had switched their preferences to daily oral drug usage. Around 60% of men did not care about the nature of the drug, i.e., an antidepressant. The most frequently reported argument to prefer daily drug treatment was that this strategy would have the least effects toward the spontaneity of having sex.
As opposed to agents that must be taken 4-6 hours prior to coitus and with the methods used here, this group of Dutch men with lifelong PE favor uninterrupted daily drug treatment to delay ejaculation mainly because daily treatment guarantees no interference with the spontaneity of having sex.
Premature ejaculation (PE) is a frequent male sexual complaint.This occurrence does not automatically imply the existence of a male sexual disorder. The current DSM definition of PE has a low positive predictive value with a high associated risk for false-positive diagnoses of PE. A new classification in four well-defined PE syndromes has recently been proposed for the pending DSM-V. According to this new classification there are different pathophysiologies and treatments of PE, dependent on the underlying PE syndrome. Some types are particularly neurobiologically or medically determined and need drug treatment; other types, which are mainly psychologically determined, need psychotherapy or both drug treatment and psychotherapy. A meta-analysis of all selective serotonin reuptake inhibitors (SSRIs) and clomipramine studies, which were performed according to current standards of evidence-based medicine, demonstrated a similar efficacy for the daily treatment with the serotonergic antidepressants paroxetine hemihydrate, clomipramine, sertraline, and fluoxetine, with paroxetine hemihydrate exerting the strongest effect on ejaculation. On-demand treatment with SSRIs generally exerts much less ejaculation delay than daily SSRI treatment. Other on-demand treatment options are the topical use of anesthetics, tramadol, and phosphodiesterase type 5 inhibitors. Caution is needed with tramadol with regard to its potential addictive properties. There is insufficient evidence for the ejaculation delaying effects of phosphodiesterase type 5 inhibitors and intracavernous injection of vasoactive drugs.
Finally someone who gets it. Of course it is a scheme to enrich insiders. This company's filings make it about as obvious as it can get. I would not be surprised to see others figure it out and the stock get crushed. Fair value is about $2M or 7 cents a share on ce the cash is dried up in two quarters.
It actually gets worse when you dig into the PE drug. Biovail (bought by VRX) had started a pair of ~1000 patient studies (links below).
If you look at the paper AMPE published, they only reported on data from a total of 604 patients. This is bad for a couple of reasons. 1, with 604 out of 2100 patients evaluated the original statistical plan can't possibly be valid.
2, if you look at VRX's 2010 10-k, the company states "we cancelled the Phase 3 clinical trials that were underway in Europe for BVF-324 (the use of non-commercially available doses of tramadol for the treatment of premature ejaculation), due to slower-than-anticipated enrolment and a lack of commercial interest in the product". Neither of these point to any actual interest in buying the drug.
The company's other "drugs" are smoke and mirros (an oral steroid to treat DME, come on....), and a diketopipierazine fragment of HSA to treat knee pain? You have to be kidding.
AMPE seems like a scheme to enrich the shareholders of DMI, who will no doubt dump the cheap shares they bought once the lockup expires. This valuation is ridiculous and I am shorting every possibe share I can.
STATE STREET CORPORATION 239,000 0.83 1,861,810 Jun 30, 2011
NORTHERN TRUST CORPORATION 221,823 0.77 1,728,001 Jun 30, 2011
TIAA-CREF INVESTMENT MANAGEMENT, LLC 111,183 0.39 866,115 Jun 30, 2011
MORGAN STANLEY 56,727 0.20 441,903 Jun 30, 2011
You missed the first third of the list??
Those are the top institutional holders. It clearly refutes your comment of "zero institutions holding the shares?"
You have your own agenda...good luck.
Do your homework:
"About the Study
The two Phase III trials for Zertane™ were conducted in 62 sites and 11 countries in Europe (results recently published in European Urology). In the open label extension trial, all subjects participating in this study (n=101) received the higher dose of Zertane™ (89 mg), and were evaluated at 3-week intervals for a total of four visits. Safety data collected during the open label extension period included laboratory tests, vital signs, electrocardiograms, adverse events, serious adverse events and treatment emergent adverse events."
"Design, setting, and participants: We conducted an integrated analysis of two identical 12-wk randomized double-blind, placebo-controlled phase 3 trials across 62 sites in Europe. Healthy men 18–65 yr of age with a history of lifelong PE according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, and an IELT _120 s were included. There were 604 intent-to-treat subjects included in the analysis."
How many people take Viagra? And yet..."It was initially studied for use in hypertension (high blood pressure) and angina pectoris (a symptom of ischaemic heart disease)." Would you take a drug for high blood pressure for erectile dysfunction? Seriously? The obvious answer was a resounding "YES." Now consider that as Viagra comes off of patent, combining it with a PE drug (initially for pain or anything else). Wonder whether anyone will buy it?