1) Results were strong enough for the FDA to grant approval
2) there is an immediate an urgent need of a safer medication
3) If they had a delay in the decision they would have announced it already (the FDA communicates it well in advance if they cannot make it for a certain deadline)
4) Since no delay, then they must have received the decision news yesterday
5) If it was bad news they would have released yesterday after hours whereas they want to have a maximum impact with a morning PR
One of the most intelligent post. Bump. If it was not illegal, it would be quite entertaining to watch how HF's have been manipulating LPCN price today and the past several months.
I do not think there is a rule. I have seen many announcements done during trading hours, after trading has been suspended pending announcement
while you laugh, I keep buying. We'll talk again about it in 3 years time, when most of patients on gel and patches would have switched to the only approved oral therapy. GLTU
Sgk, the problem is with management IMO. They are not well focussed. Too many small and short trials . I may come back when they finally clarify and streamline the path to market as far as LC is concerned
SAN DIEGO — A novel oral testosterone formulation (LPCN 1021, Lipocine), which was shown to be safe and effective at 13 weeks, continues to demonstrate similar results at 52 weeks, according to new data.
The formulation is currently under review at the US Food and Drug Administration (FDA).
Longer-term safety data are especially important because other testosterone pills in the United States have been "rarely" used because of liver toxicity, said Mohit Khera, MD, a urologist at the Baylor College of Medicine in Houston.
Dr Khera presented 52-week results from the phase 3 Study of Androgen Replacement (SOAR) here at the American Urological Association 2016 Annual Meeting.
"There is no liver toxicity because LPCN 1021 is absorbed by the lymphatic system," he told Medscape Medical News.
"There's no liver toxicity at all," confirmed Tobias Köhler, MD, a urologist at Southern Illinois University in Springfield, who moderated the press conference at which Dr Khera spoke.
SOAR was a "well-done trial," said Dr Köhler. "The science is very good."
In the multicenter open-label trial of 315 hypogonadal men, 210 men were randomized to twice-daily oral LPCN 1021 at a starting dose of 225 mg and 105 men were randomized to testosterone gel 1.62%.
All men were 18 to 80 years of age and had testosterone levels below 300 ng/dL.
The LPCN 1021 dose could be titrated up if 24-hour average testosterone concentration remained below 300 ng/dL, and could be titrated down if maximum concentration was above 1500 ng/dL.
For this formulation of LPCN 1021, the FDA set average testosterone concentrations from 300 to 1140 ng/dL.
At week 13, the mean 24-hour average testosterone concentration was 446 ng/dL, consistent with nonoral testosterone replacement therapies, as previously reported by Medscape Medical News.
The new data show that those week 13 levels "were reliably maintained through 52 weeks."
Specifically, levels were reliably restored and maintained in the eugonadal range for approximately 87% of hypogonadal men over 52 weeks.
"The efficacy is on par with androgel," Dr Köhler noted. The levels are "excellent."
If the product is approved by the FDA, it will likely be well received by clinicians and patients. "This is the most convenient testosterone formulation we have," he said.
And now, for the first time, what is convenient has been shown to be safe, he added, echoing Dr Khera's comments about the hepatotoxicity of other oral testosterones available in the United States.
Gastrointestinal disorders are an adverse event of concern with oral therapy, said Dr Khera, but there was no significant difference in adverse events between the LPCN 1021 group and the testosterone gel group.
The most common drug-related adverse events over the 52 weeks for LPCN 1021 and testosterone gel were acne (2.9% vs 2.9%), headache (0.5% vs 3.8%), weight increase (2.4% vs 0.0%), hematocrit increase (1.9% vs 0.0%), liver enzyme level increase (1.4 % vs 0.0%), fatigue (0.5% vs 1.9%), and hypertension (0.5% vs 1.9%).
Lipid parameters (cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides) were comparable in the two treatment groups at week 52.
Changes in androgenic parameters from baseline to week 52 — such as hematocrit, hemoglobin, platelet, prothrombin, and prostate-specific antigen — were not significantly different between the two groups.
Dr Khera pointed out that LPCN 1021 must be taken with a meal that includes 15 g of fat, which is the amount in a sausage biscuit, half a cup of trail mix, or two pancakes.
Global TRT market is expected to grow to $6.5B in 2020. A 25% market share (but it could be more than that if stays as the only oral drug on the market) would mean $1.6B or $8B market cap by avg pharma multiples or $400 per share with 20M O/S. Then you have the pre-term birth drug with good potential in a $1B market (just for the US).
Make no mistakes tomorrow or in the next few days, as HF's will try all possible tricks to steal your shares, trying to convince you that the drug will be rejected or even after the approval, manipulating price down after an initial spike.
Yahoo Finance has raised the 1 year vg target price from $25 to $30. Of the 3 analysts covering the stock, the lowest TP is $20, the highest $40
Actually the global market is at least double that, projecTed to reach $6.5b by 2020
I agree, it is always the same BS with this stockmarket. The good thing is that as long as they keep playing their games, we can buy at very low prices.
' Our lead product, LPCN 1021, is an oral formulation of the chemical testosterone undecanoate ("TU"), an eleven carbon side chain attached to testosterone. TU is an ester prodrug of testosterone, which is an inactive form of testosterone. Upon the cleavage, or breaking, of the ester bond, the pharmacologically active drug, testosterone is formed. An ester is a chemical between an acid and alcohol. TU has been approved for use outside the United States for many years for delivery via intra-muscular injection and in oral dosage form and TU recently received approval in the United States for delivery via intra-muscular injection. However, the oral dosage form which is approved outside the United States provides sub-therapeutic serum testosterone levels at the approved dose. We are using
our Lip’ral technology to facilitate steady gastrointestinal solubilization and absorption of TU for convenient twice daily dosing of TU'
very likely because it has met its primary efficacy endpoint and it has no safety concerns. Let us also not forget that the same drug has been approved and commercialized outside the US for many years. What else you would need? The only reason why I could possibly think this does not get approved on Tuesday is if somebody in the FDA gets a bribe to not approve it
With $38M in cash and no debt, current drugs valuation is less than $100M. Normally $100M market cap pharma do $20M in annual revenue. If everything goes according to plan (approval on or before June 28th is no brainer at this point, the drug is so effective and safe that the FDA did not even request and ADCOM) we are looking in fact as Androgel like or possibly higher annual revenue, ie $1-2B per annum, which would support a $5-$10B market cap, without even considering preterm birth product now in ph2. There is good chance we will have a $10B market cap company within a few years (if it doesn't get bought out before). That is almost 100 times current market cap, and that is not pipe dream as the TRT product will be approved on Tuesday and it is far superior to current marketed products as far as safety and compliance is concerned (whilst having similar efficacy to Androgel, the market leader)
Global Market is projected to $6B in 2020. A 20% market share would be equal to $1.2B in revenue or $7B in market cap, vs current $130M market cap. Easy money
Wellesley, Mass. – According to a new technical market research report, PREVENTION AND TREATMENT OF PROSTATE CANCER: TECHNOLOGIES AND GLOBAL MARKETS (PHM113A), from BCC Research (www.bccresearch.com), the global market for the prevention and treatment of prostate cancer was valued at $26.1 billion in 2011 and should reach nearly $29.3 billion in 2012. Total market value is expected to reach $50.3 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 11.4%.
The global prostate cancer market can be broken down into three main segments: diagnosis and screening, surgical and radiation therapy, and drug therapeutics.
The diagnosis and screening segment is expected to total $12.1 billion in 2012 and $17.4 billion in2017, a CAGR of 7.5%
As a segment, surgical and radiation therapy should total $9 billion in 2012 and nearly $14.3 billion in 2017, a CAGR of 9.7%.
Drug therapeutics are expected to reach $8.1 billion in 2012 and nearly $18.6 billion in 2017, a CAGR of 18%.
The hallmark of cancer is uncontrolled growth and the spread of abnormal cells. The disease leads to more than 6 million deaths worldwide each year. The American Cancer Society (ACS) estimates that more than 12 million new cases of cancer are diagnosed worldwide each year. Tremendous progress has been seen in the early diagnoses and treatment methods for cancer during the past few years. Sadly, most of the current methods still in use are conventional therapies such as surgery, radiation, and chemotherapy, all with intense and serious side effects.
Prostate cancer is the most common cancer in males in the United States and other parts of the Western world. The incidence of the disease itself presents a formidable public health problem. More than 240,000 new cases were diagnosed in the United States in 2011, and there are currently approximately 2 million existing cases. It is estimated that nearly 17% of men will receive a prostate cancer diagnosis in their lifetime and that more than $8 billion is spent annually to treat prostate cancer. In 2011, more than 30,000 men in the United States died of the disease.
I Think both companies are high risk/ high reward. Possibly Galt higher risk/ higher reward. Next read out is with Galt though. NASH fibrosis ph2 in Q3. I also see Galt path to the market more straight forWard. One fibrosis trial and one cirrhosis trial