You are absolutely right. Even then, you will face losses most of the time. But at least they will be smaller.

GW Pharmaceuticals Reports Positive Phase 3 Pivotal Trial Results for EPIDIOLEX® (cannabidiol) Oral Solution in Patients with Seizures Associated With Tuberous Sclerosis Complex
GlobeNewswire•May 6, 2019
- Achieved primary efficacy measure with both EPIDIOLEX doses as compared to placebo -

- Represents the fifth consecutive positive Phase 3 pivotal trial for EPIDIOLEX -

- Expect to file sNDA in Q4 2019 -

https://finance.yahoo.com/news/gw-pharmaceuticals-reports-positive-phase-200100663.html

CARLSBAD, Calif., May 06, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc and its U.S. subsidiary Greenwich Biosciences Inc. (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced positive top-line results of a randomized, double-blind, placebo-controlled Phase 3 clinical trial of EPIDIOLEX® (cannabidiol or CBD) CV in the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), a rare and severe form of childhood-onset epilepsy. In this trial, EPIDIOLEX met its primary endpoint, which was the reduction in seizure frequency compared to baseline of the Epidiolex 25 mg/kg/day dose group vs placebo (p=0.0009). Results for both the 25 and 50 mg/kg/day dose groups were similar, with seizure reductions of 48.6% and 47.5% from baseline respectively, vs 26.5% for placebo (50 mg/kg/day vs placebo, p=0.0018). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed is consistent with findings from previous studies, with no new safety risks identified.

“The positive outcome in this trial of EPIDIOLEX in patients with Tuberous Sclerosis Complex expands both our knowledge of this newly available medicine and its potential utility beyond the current indications,” stated Elizabeth Thiele, M.D., Ph.D., Director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, Professor of Neurology at Harvard Medical School and the lead investigator of the trial. “Data from previous controlled clinical trials of EPIDIOLEX have shown clinically meaningful seizure reductions and consistent safety and tolerability in children and adults with Lennox-Gastaut syndrome and Dravet syndrome. Based on the positive results of this trial in TSC patients, EPIDIOLEX, if approved for this additional indication, may become an important treatment option also in this disease state with significant unmet medical need.”

“The positive results from this trial represent the fifth positive Phase 3 trial for EPIDIOLEX and follows the recent U.S. launch of EPIDIOLEX for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. These new data show EPIDIOLEX reduced TSC-associated seizures, which include both focal and generalized seizures types, expanding the body of reliable science supporting the use of EPIDIOLEX,” stated Justin Gover, GW’s CEO. “With these data, we look forward to submitting an sNDA to the FDA in the fourth quarter with the goal of expanding the product label in 2020 to help the lives of patients suffering with TSC.”

“Some of the most challenging and frustrating aspects of tuberous sclerosis complex (TSC) are seizures that cannot be effectively controlled by existing medications,” explained Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance, “A new safe and effective treatment option such as Epidiolex is desperately needed. Further, we are grateful to GW, the researchers and the members of the TSC community who participated in this clinical trial. We are truly excited about the potential approval of Epidiolex to treat seizures in TSC as it brings much needed hope to those with TSC and their families who live daily with this difficult disorder.”

Trial Overview and Results

Patients aged 1-65 years with a confirmed diagnosis of treatment-resistant TSC were eligible to participate in this Phase 3, randomized double-blind placebo-controlled trial. The trial randomized 224 patients into three arms, where EPIDIOLEX 25 mg/kg/day (n=75), EPIDIOLEX 50 mg/kg/day (n=73) or placebo (n=76) was added to current anti-epileptic drug (AED) treatment. The average age of trial participants was 14 years (range 1-57). On average, patients were taking 3 AEDs, having previously tried and discontinued 4 other AEDs. The most common concomitant AEDs in this trial were valproic acid (45 percent), vigabatrin (33 percent), levetiracetam (29 percent), and clobazam (27 percent).

GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2019

https://finance.yahoo.com/news/gw-pharmaceuticals-plc-reports-financial-200100422.html

GlobeNewswire•May 6, 2019
- Epidiolex U.S. Q1 net sales of $33.5m -
- Positive Phase 3 pivotal results in Tuberous Sclerosis Complex, sNDA submission expected in Q4 2019 -
- Conference call today at 4:30 p.m. EDT -

CARLSBAD, Calif., May 06, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development and commercialization of cannabinoid prescription medicines, announces financial results for the first quarter ended March 31, 2019.

“We are pleased to report a strong launch of Epidiolex in the US and continue to be encouraged by the level of support for this medicine from patients, caregivers and healthcare professionals. As the first and only plant-derived CBD medicine approved by the FDA, Epidiolex offers a novel treatment option for patients with Lennox-Gastaut Syndrome and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy”, stated Justin Gover, GW’s Chief Executive Officer. “In addition, we are delighted to report today positive results from a Phase 3 trial in patients with seizures associated with Tuberous Sclerosis Complex, and are excited at the prospect of expanding the use of Epidiolex to these high need patients in the future.”

OPERATIONAL HIGHLIGHTS

Darren Cline appointed U.S. Chief Commercial Officer
Epidiolex® (cannabidiol)
U.S. commercial update
Q1 Net sales of $33.5m
Over 7,600 patients have received Epidiolex prescriptions since launch
Over 1,900 physicians have generated dispensed prescriptions since launch
Pharmacy distribution network now includes over 145 distribution points
Approximately 75 percent of 900 patients in expanded access program and open label extension now transitioned to commercial product. Remaining patients expected to transition by end of Q2.
Rapid and encouraging payor coverage decisions
Over 90 percent of all U.S. lives now covered – 65 percent of which have either Prior Authorization (PA) to indication or less restrictive
New commercial coverage determination recently announced by United HealthCare, OptumRx and Prime Therapeutics
99 percent of State Fee-for-Service Medicaid lives now have a coverage determination with 67 percent of covered lives having either PA to indication or less restrictive
7 States covering Epidiolex without restrictions
Approximately 90 percent of Managed Medicaid lives have a coverage determination with 40 percent having a PA to indication or less restrictive
Target physician coverage
The sales organization has to date interacted with about 70 percent of the over 5,000 target healthcare professionals including all Level 3 and 4 epilepsy centers
European regulatory and pre-launch progress
CHMP opinion expected mid-2019
Launches expected in major five European markets by end of 2019
Manufacturing
Commercial manufacturing and supply chain running smoothly
Production capacity sufficient to meet expected demand in both U.S. and Europe
Clinical trials
Positive results in Phase 3 trial in Tuberous Sclerosis Complex
Primary efficacy measure achieved with both Epidiolex doses compared to placebo
sNDA submission expected in Q4 2019
IND open for pivotal Phase 3 trial in Rett Syndrome with expected start in Q2 2019
Life-cycle management
Several new formulations of CBD in development including modified oral solution, capsule and intravenous formulation
PK data expected in 2019
Exclusivity
7 years of orphan exclusivity confirmed by FDA, plus 6-month pediatric extension expected. 10 years of orphan exclusivity in Europe plus 2 year pediatric extension
Key favorable patent grants by USPTO related to the use of CBD in epilepsy
Patents align directly with new Epidiolex FDA label and listed in “Orange Book”
Patent expiry dates to 2035
Additional patent applications under review, including patents related to the use of Epidiolex in TSC
Pipeline progress
Sativex® (nabiximols)
FDA meeting in December 2018 resulted in regulatory pathway in the U.S.
Initial U.S. target indication: Multiple Sclerosis spasticity
Single Phase 3 pivotal study expect to commence in Q4 2019
Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
CBDV
Initial data from 5 patient expanded access program in patients with seizures and autism presented at American Epilepsy Society Annual Meeting suggest that CBDV is well tolerated and has potential as an AED/behavioral/cognitive medicine in the autism/epilepsy population
Company sponsored IND open for 30-patient open label study in autism
Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder has commenced recruitment
Open label study in Rett syndrome and seizures has commenced
FINANCIAL HIGHLIGHTS

Cash and cash equivalents at March 31, 2019 were $521.7 million compared to $591.5 million as of December 31, 2018
Revenue for the quarter ended March 31, 2019 was $39.2 million compared to $3.0 million for the quarter ended March 31, 2018
Net loss for the quarter ended March 31, 2019 was $50.1 million compared to $69.5 million for the quarter ended March 31, 2018
Closed transaction to sell Rare Pediatric Disease Priority Review Voucher for $105 million on April 5, 2019. The sale will be reflected in our Q2 2019 results
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending March 31, 2019 financial results today at 4:30 pm EDT. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 47716.

Wow - Was that plagiarized word for word from Hannity's daily script? Nice puppetry Biggie! You may now return to your Foxhole. LOL

Yes, I do enjoy Florida, hot and humid summers notwithstanding. As you may or may not remember, I moved here from the Northeast (northern Delaware) 21 years ago. The Northeast just wasn't doing it for me, so I packed up my bags, and moved Southerly (South Florida, that is).:) I'll be heading back home tomorrow for my Mom's birthday. How's the weather up there?

As far as investments, I'm all over the place. Fairly well diversified. Unfortunately, even after Cortex, I had another big bust with little pseudo biotech called star scientific (then rock creek pharma). The founder, Johnny Williams, was a real swindler/snake salesman. He was even involved in a bribe/misappropriation case which brought down the governor of Virginia. I had some good ones/wins, also, including GW Pharma, which I started buying at 99, all the way down to the 30's. My persistence paid off there, a rare feat! That was just before they announced the stellar results of Epidiolex in Dravets Syndrome. Still have it.

I have also been playing the cannabis market, and have done well. One of them, NEPT, was by accident. I liked their krill oil product, but the business was dwindling. I amassed 10000 shares when riding it down to .80+ cents. Then, they decided to sell their Krill business and focus exclusively on extracting CBD from cannabis. That was so freaking lucky. They ended up signing a big deal with Canopy Growth. I still hold a few thousand shares. I also have a hemp play (Hemp food and fiber, now %53 owned by Aurora). I own Canntrust, which is a relatively fairly valued Canada medical and rec. cannabis player that seems to be well run. In addition, I have a US cannabis play, Golden Leaf, which has stores in Oregon, Nevada, etc. and may have some future potential as rec use continues to expand, and hopefully, the Federal Gov't changes their tune. It's time.

in addition, I like to take advantage of beaten down good or conservative companies in all sectors: BTI, T, DISH, TWTR, ESLT, KR, WTR, P. Still have some biotechs, too: BLRX, BCLI, ALKS, INCY.

To Hedge, I've also been building and unwinding leveraged shorts: QID, SQQQ, and UVXY. They were killing me for 1 1/2 years...I never believed the hype after the Trump win, but paid a price on these. Fortunately, I've dwindled the positions down to a small position as the markets swung down, and was 85-85% long on the market.

Hope you don't still support that lunatic Alex Jones. That guy's mind is about as sick as you can get. Unless it is just about the money and publicity, then we're talking on par with Trump.

Take it easy for now.

The last thing we need here in Florida is another GOP'er monkeying up our election results! :) Desantis is a pure Trump puppet, a yes man, kiss ass, brown noser. Where's the integrity in that?

Hope all is well with you GFP!

GWPH - Curious to see the popularity of off-label use.

https://finance.yahoo.com/news/epidiolex-cannabidiol-oral-solution-first-104500250.html

EPIDIOLEX® (cannabidiol) Oral Solution – the First FDA-approved Plant-derived Cannabinoid Medicine – Now Available by Prescription in the U.S.
GlobeNewswire•November 1, 2018
- Medication indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two rare, severe childhood-onset epilepsies -

- Comprehensive support program available for eligible patients -

LONDON and CARLSBAD, Calif., Nov. 01, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), the world leader in the development and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, announced today that EPIDIOLEX® (cannabidiol) oral solution CV is now available in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. EPIDIOLEX, which was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018, is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.

“We are delighted to announce that EPIDIOLEX is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures. We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”

The company has introduced a comprehensive patient support program called EPIDIOLEX Engage™, which is designed to help patients who have been prescribed EPIDIOLEX gain access to therapy. The program offers patient/caregiver-focused education and resources to help lower out-of-pocket costs or provide product at no cost for eligible patients. More information can be found at EPIDIOLEX.com.

“EPIDIOLEX is a much-needed new treatment option for patients with LGS, a rare and severe form of childhood-onset epilepsy that typically persists into adulthood,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “Despite the use of multiple epilepsy treatments, the majority of LGS patients continue to have life-long, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option.”

“We are very pleased that EPIDIOLEX -- the first medication to be approved by the FDA for patients with Dravet syndrome -- is now available,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. “Our community has long desired a medication specifically approved for the treatment of seizures associated with Dravet syndrome, and the availability of EPIDIOLEX is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy.”

The EPIDIOLEX clinical development program included three randomized, controlled Phase 3 clinical trials and an open-label extension study. The Phase 3 studies have been published in The New England Journal of Medicine1,[2] and Lancet3. EPIDIOLEX added to other antiepileptic therapies significantly reduced the frequency of drop seizures in patients with LGS and convulsive seizures in patients with Dravet syndrome. The most common adverse reactions that occurred in EPIDIOLEX-treated patients were somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor quality sleep; and infections. The company’s development program represents the only well-controlled clinical development program of a cannabinoid medication leading to FDA approval for patients with LGS and Dravet syndrome.

EPIDIOLEX was developed by GW Pharmaceuticals and will be marketed in the U.S. by its subsidiary, Greenwich Biosciences. For more information on EPIDIOLEX, visit www.EPIDIOLEX.com.

The Canadian cannabis mania is somewhat off-topic, however, the current valuations make GWPH look cheap.

ACOR up 25% today on high volume, but no news that I'm aware of. Any clues?

Re: GWPH

Marijuana-based drug gets positive review from US agency

https://finance.yahoo.com/m/bc036411-8695-36f3-863b-48b1716e5484/ss_marijuana-based-drug-gets.html

Associated Press Associated PressApril 17, 2018
WASHINGTON (AP) — U.S. health officials say a closely watched medicine made from the marijuana plant significantly reduces seizures in children with severe forms of epilepsy and warrants approval in the country.

The Food and Drug Administration posted its review Tuesday of the experimental medication ahead of a public meeting later this week.

British drugmaker GW Pharmaceuticals is seeking approval to sell its purified form of an ingredient found in cannabis — one that doesn't get users high — as a medication for hard-to-treat seizures in children. If successful, the company's liquid formula would be the first government-approved drug derived from the cannabis plant in the U.S.

A greenlight for the medicine could also spur new pharmaceutical research and interest into other cannabis-based products.

Acasti Pharma Announces Development and Commercialization Discussions Progressing with a Leading China Pharmaceutical Partner

https://finance.yahoo.com/news/acasti-pharma-announces-development-commercialization-130000829.html

LAVAL, QUEBEC--(Marketwired - Nov 20, 2017) - Acasti Pharma Inc. (ACST)(TSX VENTURE:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that the company recently entered into a non-binding term sheet with a leading China-based pharmaceutical company. Completion of the transaction is subject to further negotiation and execution of a definitive agreement, which once signed would grant an exclusive license to the Chinese pharmaceutical company to commercialize CaPre in certain Asian countries, including China. With the high prevalence of hypertriglyceridemia in Asia, this potential partnership presents a significant opportunity for Acasti and CaPre.

If a definitive agreement is reached and signed, the term sheet contemplates that Acasti would receive an upfront payment of US$8 million upon signing, plus potential additional regulatory and commercial milestone payments in excess of US$125 million, and tiered double-digit royalties on net sales. The term sheet is preliminary and non-binding at this stage and the license, upfront payment, possible milestone payments, and royalties contemplated by it will only become operative if definitive documents are executed. It is possible that no definitive agreement will be reached or, if a definitive agreement is reached, that its terms or conditions may differ from those described above.

About CaPre® (omega-3 phospholipid)

Acasti's prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either "free" or bound to phospholipids that allows for better absorption into the body. This allows for enhanced bioavailability and EPA and DHA blood levels compared to the "esterified" fish-oil omega-3 options such as LOVAZA.

About Acasti Pharma

Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. The company's strategy is to initially develop and commercialize CaPre for the 3 to 4 million patients in the U.S. with severe hypertriglyceridemia. Since its founding in 2008, Acasti Pharma has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. For more information, visit www.acastipharma.com.

That is very antiquated, and ill-informed, thinking. The system itself is mostly to blame for lack of studies. However, synthetic THC HAS been approved for decades (dronabinol) for various non-emotional conditions, and continues in trials for other non-emotional conditions.

Furthermore, GWPH has just completed 4 successful Ph3 trials in seizure disorders (using marijuana based cannibidiol), which traditional seizure medications have failed to treat. FDA approval is likely in early 2018, barring senseless political resistance, and this may very well be the catalyst to put to rest much of the doubt of marijuana as a legitimate medical treatment.

Can it be abused, overused, and excused by certain users, which counters its therapeutic benefit? Of course, but that goes for virtually anything we consume.

Neptune enters into Commercial Distribution Joint Venture in China with Shanghai Chonghe Marine Industry Co., Ltd.

http://finance.yahoo.com/news/neptune-enters-commercial-distribution-joint-210000432.html

LAVAL, QUEBEC--(Marketwired - Apr 5, 2017) - Neptune Technologies & Bioressources Inc. ("Neptune") (NEPT.TO)(NEPT.TO) is pleased to announce that it has signed a commercial distribution joint venture agreement with Shanghai Chonghe Marine Industry Co., Ltd. ("CMI") through a wholly-owned subsidiary of CMI, Jiangsu Sunline Deep Sea Fishery Co., Ltd. ("Sunline Fishery").

Under the agreement, Neptune will own a 30% interest in the joint venture while CMI/Sunline Fishery will hold 70%. Our Chinese partners have a strong presence in the biomarine industry in China, including a state-of-the-art krill harvesting vessel now under construction. The joint venture will greatly enhance Neptune's commercial presence in China. Furthemore, Neptune will contribute to this joint venture with its IP, science, regulatory expertise, branding, industry sales knowledge and international recognition. Shipments of krill oil under the joint venture are projected to start in Q1 ending June 30, 2017.

"Canada is one of the very few countries that are currently allowed to export krill oil into China. The purpose of this joint venture is to accelerate Neptune's growth in China, one of the fastest growing Omega-3 markets in the world. Furthermore, this partnership will help secure procurement of our raw materials, while also strengthening the future of Neptune's presence in the growing Aquaculture business," stated Jim Hamilton, President & CEO of Neptune.

"We came to the conclusion that to become a leader in our mainland, as well as to develop international recognition and presence in the biomarine related krill fisheries, we needed to be associated with the pioneer and the first company to have vested largely in science on both the human nutrition side and pharmaceutical research," concluded Wang Zhi, President & CEO of CMI.

Ouch! eom

Where is Trump when you need him? Not enough golfers in CAT's executive suite; can't tweet because he's out to dinner; or, he is biased towards Deere? One can only wonder with him, lol.

Caterpillar to close Illinois plant, lay off 800 workers

http://finance.yahoo.com/m/4fbdd98b-d389-343a-9e43-81a41e2fd302/caterpillar-to-close-illinois.html

Associated Press Associated PressMarch 31, 2017
PEORIA, Ill. (AP) — Caterpillar Inc. has announced the closing of its facility near Aurora, Illinois, and the lay off 800 workers.

Earlier this year, the earth-moving equipment maker said it would lay off employees in 2017 because of an anticipated decline in demand for its products.

Caterpillar spokeswoman Lisa Miller said Friday the large wheel loaders and compactor production will be moved to the company's Decatur, Illinois, plant. Its medium wheel loader production line will be moved to the North Little Rock, Arkansas, plant.

Miller said moving production from Aurora will allow the company to take advantage of utilized production facilities while preserving capacity for an upturn in demand.

Miller says the company will maintain an Aurora office for engineers and product support employees.

Caterpillar in January reported a fourth-quarter loss of $1.17 billion on revenue of about $9.6 billion.

Sorry...thought I did. The link started there but wound up here.

Caterpillar to close Illinois plant, lay off 800 workers

http://finance.yahoo.com/m/4fbdd98b-d389-343a-9e43-81a41e2fd302/caterpillar-to-close-illinois.html

Associated Press Associated PressMarch 31, 2017
PEORIA, Ill. (AP) — Caterpillar Inc. has announced the closing of its facility near Aurora, Illinois, and the lay off 800 workers.

Earlier this year, the earth-moving equipment maker said it would lay off employees in 2017 because of an anticipated decline in demand for its products.

Caterpillar spokeswoman Lisa Miller said Friday the large wheel loaders and compactor production will be moved to the company's Decatur, Illinois, plant. Its medium wheel loader production line will be moved to the North Little Rock, Arkansas, plant.

Miller said moving production from Aurora will allow the company to take advantage of utilized production facilities while preserving capacity for an upturn in demand.

Miller says the company will maintain an Aurora office for engineers and product support employees.

Caterpillar in January reported a fourth-quarter loss of $1.17 billion on revenue of about $9.6 billion.

ACOR: Acorda Announces Long-Term Safety Data for CVT-301

http://finance.yahoo.com/news/acorda-announces-long-term-safety-100000102.html

ARDSLEY, N.Y.--(BUSINESS WIRE)--

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced results from two ongoing, long-term safety studies of CVT-301 in people with Parkinson’s that showed no differences in pulmonary function between the group receiving CVT-301 and an observational control group. These results are consistent with previously reported data from Phase 2b and Phase 3 clinical trials.

CVT-301 is an investigational, inhalable formulation of levodopa (L-dopa). It is being studied as a treatment for symptoms of OFF periods in people with Parkinson’s taking an oral carbidopa / levodopa regimen. OFF periods are characterized by the re-emergence of Parkinson’s symptoms.

“We are delighted with these results, and plan to move forward with our NDA filing for CVT-301. These two studies, which include approximately 700 participants, represent the largest safety database evaluating long-term pulmonary function in people with Parkinson’s,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We thank the study volunteers and clinical investigators, whose willingness to participate in these trials has been essential to the progress of this program.”

ACOR - Decent recovery from its Nov '16 low of $16.40/sh (now over $30/sh):

http://finance.yahoo.com/news/patent-trials-appeal-board-ptab-204300308.html

Patent Trials and Appeal Board (PTAB) Upholds Four AMPYRA® Patents

Business Wire Business Wire March 9, 2017

ARDSLEY, N.Y.--(BUSINESS WIRE)--

Acorda Therapeutics, Inc. (Nasdaq: ACOR ) today announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld all four patents challenged via the inter partes review (IPR) process. U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent) apply to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. These patents are set to expire in 2025, 2025, 2026 and 2027, respectively.

“The court decision reflects the merits of the case we presented and the validity and strength of our intellectual property for AMPYRA,” said Ron Cohen, M.D., Acorda's President and CEO. “Medical innovation depends on the recognition of valid intellectual property claims. Our in-house legal team and external counsel presented a compelling case, and will continue to defend the validity of our intellectual property rights for AMPYRA.”

Acorda was advised by Gerald Flattmann, Naveen Modi, Thomas Phalen, Michael Stamiello, Daniel Zeilberger, and Lucas Kressel of Paul Hastings LLP.

These patents, as well as U.S. Patent No. 5,540,938 that also pertains to AMPYRA, have also been challenged in the U.S. District Court for the District of Delaware. The Court has completed the trial of the case, but not yet issued its decision.

Interestingly, another medical aesthetics company based in Israel (ELOS) is also getting buyout interest:

Apax Partners in talks to buy Israel's Syneron Medical -report

Reuters February 13, 2017

JERUSALEM, Feb 13 (Reuters) - British private equity fund Apax Partners is in talks to buy Israel-based Syneron Medical , an aesthetic device company, for $350-$400 million, Israeli financial daily Calcalist reported on Monday.

Representatives from Apax met Syneron executives in Israel last week and the talks are being managed by Barclays, according to Calcalist, a leading Israeli publication, which did not name its sources.

Spokespeople in Israel for Apax and Barclays would not comment on the report. Officials at Syneron were not reachable for immediate comment.

Syneron says its products have a range of applications, like body contouring, hair removal and wrinkle reduction. The products are sold under two brands, Syneron and Candela.

Indeed...in both directions. But, since it is nearly impossible to pick the bottom (or the top), and the pps is outside the normal "range", why get cute? You're right though, cash can kill if good opportunities are being passed up or ignored altogether. I am confident they aren't sitting idly by, and the value is there. It could be a long term investment, and at this point, also a good short to midterm trade. That's the beauty of a downtrodden stock of a strong, established company. There are too many strong companies you can't say that about right now. My feeling is there could be rotation in.

What's 5 points matter in this scenario?

Understood. At this pps, however, It looks to be a low risk/potentially high reward scenario. Gilead has plenty of available cash, they're patient and frugal as an acquirer, and they pay a decent dividend. I'd call it a no-brainer if it wasn't so cliche :)

Acorda Announces Positive Phase 3 Clinical Trial Results for CVT-301

http://finance.yahoo.com/news/acorda-announces-positive-phase-3-110000178.html

ARDSLEY, N.Y.--(BUSINESS WIRE)--

Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced Phase 3 clinical data of CVT-301, showing a statistically significant improvement in motor function in people with Parkinson’s disease experiencing OFF periods. CVT-301 is an investigational, inhalable formulation of levodopa (L-dopa). It is being studied as a treatment for OFF periods in people with Parkinson’s disease taking an oral carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms.

“We are greatly encouraged by the efficacy and safety results of this trial, which validate the positive Phase 2b results,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We would like to express our gratitude to the study volunteers and clinical investigators who participated in this trial to advance our understanding of this potentially important therapy for people with Parkinson’s.”

The SPAN-PD trial had three arms: CVT-301 84 mg and 60 mg doses (equivalent to 50 mg and 35 mg fine particle doses, respectively), and placebo. The primary endpoint of the study was the change at Week 12 in Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment for the 84 mg dose. UPDRS III change for the 84 mg dose was -9.83 compared to -5.91 for placebo (p=0.009). UPDRS III is a validated scale, which measures Parkinson’s motor impairment.

The safety profile of CVT-301 in this study was consistent with that observed in the Phase 2b trial. Spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) tests showed no notable pulmonary safety signals. The Company is currently conducting two studies to assess the long-term safety profile of CVT-301. Up to 12-month data from these studies are expected by the end of the first quarter of 2017.

The Company plans to file a New Drug Application (NDA) in the United States by the end of the second quarter of 2017, pending results of the long-term safety studies. The Company also plans to file a Marketing Authorization Application (MAA) in Europe by the end of 2017, pending additional data analyses.

Peter LeWitt, M.D., M.Med.Sc., Director of the PD and Movement Disorders Program at Henry Ford Hospital and lead investigator of the study said, “The re-emergence of Parkinson’s disease symptoms has a major negative impact on the lives of people with this disease, as well as on their families and care partners. Managing symptoms of OFF periods continues to be a significant unmet need for people taking oral carbidopa/levodopa regimens. Delivering levodopa by the pulmonary route offers an important treatment option for people with Parkinson’s disease.”

Detailed trial results will be presented at a future medical meeting.

It is safe to say that GILD is less of a gamble than most,if not all,of the biotechs discussed on this board.

Biotechnology Executives Oppose Trump Immigration Policy

http://www.forbes.com/sites/matthewherper/2017/02/07/biotechnology-executives-oppose-trump-immigration-policy/?utm_source=yahoo&utm_medium=partner&utm_campaign=yahootix&partner=yahootix#63f05c1d2d5e

Matthew Herper , FORBES STAFF

Nearly 100 founders and leaders of biotechnology companies have signed a letter rebuking President Donald Trump for the immigration restrictions he put in place through an executive order on January 27. The letter is being published by Nature Biotech, a top scientific journal.

The letter expresses "deep concern and opposition" to Trump's executive order barring the entry of citizens from seven countries. The letter notes that one study showed that 52% of the 69,000 biomedical researchers in the United States were foreign-born. And then it goes further, warning that the policy could deeply damage U.S. leadership in the development of new medicines.

"If this misguided policy is not reversed," the letter writers state, "America is at risk of losing its leadership position in one of its most important sectors, one that will shape the world in the twenty-first century. Indeed, it will harm an industry dominated by smaller companies and startups, the very kind of industry the administration has said it wants to support. It will slow the fight against the many diseases that afflict us, as well as carry negative economic consequences for the United States."

The letter states:

Every nation has the right to determine who comes across its borders. Every nation needs to be vigilant in defending itself against and hunting down terrorists. The actions taken by the Trump administration, however, were poorly conceived and implemented; they have raised deep fears and concerns across the biotech industry, in which diversity and the free flow of ideas and people have created an American powerhouse of medicine.

If this misguided policy is not reversed, America is at risk of losing its leadership position in one of its most important sectors, one that will shape the world in the twenty-first century. Indeed, it will harm an industry dominated by smaller companies and startups, the very kind of industry the administration has said it wants to support. It will slow the fight against the many diseases that afflict us, as well as carry negative economic consequences for the United States.

America must remain the world’s greatest engine of innovation, as well as the beacon of liberty it has been for more than 200 years. The two are inextricably intertwined. Organizers of the letter Jeremy M. Levin, the chief executive of Ovid Therapeutics, Steven Holtzman, the chief executive of Decibel Pharmaceuticals, John Maraganore, the chief executive of Alnylam Pharmaceuticals, and Ron Cohen, the chief executive of Acorda Therapeutics.

GW Pharmaceuticals Achieves Positive Results in Phase 2 Proof of Concept Study in Glioma

http://finance.yahoo.com/news/gw-pharmaceuticals-achieves-positive-results-120000508.html

LONDON, Feb. 07, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced positive top-line results from an exploratory Phase 2 placebo-controlled clinical study of a proprietary combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in 21 patients with recurrent glioblastoma multiforme, or GBM. GBM is a particularly aggressive brain tumor, with a poor prognosis. GW has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for THC:CBD in the treatment of glioma.

The study showed that patients with documented recurrent GBM treated with THC:CBD had an 83 percent one year survival rate compared with 53 percent for patients in the placebo cohort (p=0.042). Median survival for the THC:CBD group was greater than 550 days compared with 369 days in the placebo group. THC:CBD was generally well tolerated with treatment emergent adverse events leading to discontinuation in two patients in each group. The most common adverse events (three patients or more and greater than placebo) were vomiting (75%), dizziness (67%), nausea (58%), headache (33%), and constipation (33%). The results of some biomarker analyses are still awaited.

“The findings from this well-designed controlled study suggest that the addition of a combination of THC and CBD to patients on dose-intensive temozolomide produced relevant improvements in survival compared with placebo and this is a good signal of potential efficacy,” said Professor Susan Short, PhD, Professor of Clinical Oncology and Neuro-Oncology at Leeds Institute of Cancer and Pathology at St James’s University Hospital and principal investigator of the study. “Moreover, the cannabinoid medicine was generally well tolerated. These promising results are of particular interest as the pharmacology of the THC:CBD product appears to be distinct from existing oncology medications and may offer a unique and possibly synergistic option for future glioma treatment.”

“We believe that the signals of efficacy demonstrated in this study further reinforce the potential role of cannabinoids in the field of oncology and provide GW with the prospect of a new and distinct cannabinoid product candidate in the treatment of glioma,” stated Justin Gover, GW’s Chief Executive Officer. “These data are a catalyst for the acceleration of GW’s oncology research interests and over the coming months, we expect to consult with external experts and regulatory agencies on a pivotal clinical development program for THC:CBD in GBM and to expand our research interests in other forms of cancer.”

The study, designed to evaluate a number of safety and efficacy endpoints, comprised an initial phase where the safety of THC:CBD in combination with dose-intense temozolomide (an oral alkylating agent that is a standard first-line treatment for GBM) was assessed in 2 cohorts of 3 patients each. Following a satisfactory independent safety evaluation, the study then entered a randomized placebo-controlled phase where 12 patients were randomized to THC:CBD as add-on therapy compared with 9 patients randomized to placebo (plus standard of care).

Beginning in 2007 and prior to initiating this study, GW conducted substantial pre-clinical oncologic research on several cannabinoids in various forms of cancer including brain, lung, breast, pancreatic, melanoma, ovarian, gastric, renal, prostate and bladder. These studies have resulted in approximately 15 publications and show the multi-modal effects of cannabinoids on a number of the key pathways associated with tumor growth and progression. Cannabinoids have been shown to promote autophagy (the process of regulated self-degradation by cells) via several distinct mechanisms, including acting on the AKT/mTOR pathway, an important intracellular signalling pathway that is overactive in many cancers.

In glioma, THC and CBD appear to act via distinct signalling pathways. The combination of THC and CBD showed good efficacy in various animal models of glioma, particularly when used in combination with temozolomide. Initial in vitro studies showed that the combined administration of THC and CBD led to a synergistic reduction in the viability of U87MG glioma cells when compared to the administration of each cannabinoid individually. The co-administration of temozolomide with THC and CBD had further synergistic effects, causing a significant reduction in cell viability. These pre-clinical studies justified the initiation of the Phase 2 clinical study.

Mexico will 'immediately' respond to any U.S. border tax: minister

https://www.yahoo.com/news/mexico-immediately-respond-us-border-tax-minister-153823518.html

Reuters January 13, 2017

MEXICO CITY (Reuters) - Mexico must be ready to respond immediately with its own tax measures if the incoming administration of President-elect Donald Trump imposes a border tax, the economy minister said on Friday, warning such protectionism may trigger a global recession.

Trump, who takes office on Jan. 20, has promised a "major border tax" on companies that shift jobs outside the United States, and such a measure could hobble Mexico's exports to its top trading partner.

"It is clear we need to be prepared to immediately neutralize the impact of such a measure," Economy Minister Ildefonso Guajardo said in an interview on Mexican television.

"And it is very clear how - take a fiscal action that clearly neutralizes it," he said.

Trump has repeatedly attacked Mexico over trade, jobs and immigration since he first launched his run for the White House in 2015, driving the peso currency to historic lows and unnerving investors, especially in the auto sector.

Guajardo said Trump's proposed tax "was a problem for the entire world" and that it "would have a wave of impacts that could take us into a global recession."

Nonetheless, the minister said he expected foreign direct investment in Mexico this year to total around $25 billion, with investment in the energy and telecommunications sectors expected to more than make up for the loss of a planned $1.6 billion Ford Motor Co. factory that the company said this month it is cancelling. Trump had strongly criticized the plan, but Ford said its decision was not the result of pressure from Trump.

Guajardo also praised the government of Japan and Toyota Motor Corp <7203.T> for their "reasonable" response to Trump's threat to impose a significant border tax if the company does not stop making its Corolla model in Mexico for the U.S. market. Toyota said last week the automaker has no immediate plans to curb production in Mexico.

"Toyota has 10 plants in the United States... and employs more than 130,000 Americans. If I were Mr. Trump, I'd treat them with more respect," Guajardo said.

He added that he expects total foreign direct investment during the six-year term of President Enrique Pena Nieto, which ends in late 2018, to average $30 billion annually.

Guajardo has previously warned that U.S. corporate tax cuts proposed by Trump, as well as the border tax, could undermine foreign investment in Latin America's No. 2 economy.

Mexico slapped a tax on U.S. high fructose corn syrup in the early 2000s after the United States refused to allow free trade in Mexican sugar.

(Reporting by Michael O'Boyle; Editing by Frances Kerry)

ACOR: Still dropping. This is all I got, as to why:

https://twitter.com/adamfeuerstein/status/780433371629486084

ACOR: Stock dropped hard yesterday on high volume...no news last two days except for the suspension of trading of the shares of the company they acquired in Finland (Biotie). Dropping again today, now @ 4 year low.

GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for Epidiolex® (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

GlobeNewswire•September 26, 2016
- Primary endpoint achieved in both Epidiolex doses with high statistical significance compared to placebo -
- Today’s data represents the third positive Phase 3 pivotal trial for Epidiolex reported in 2016 -

- Data reinforce the potential of Epidiolex to be an important new medicine for patients who suffer from this treatment-resistant childhood-onset epilepsy -
- Company to hold investor conference call today at 8:00 a.m. EDT/13:00 BST -

http://finance.yahoo.com/news/gw-pharmaceuticals-announces-second-positive-105700589.html

I believe the misinformation is purposeful, it's sensationalism designed to impassion (mostly) the intellectually shallow. Fox News has cornered the market with that formula. Thank you for digging deeper and finding something closer to the truth.

As far as "jumping the gun", what a fitting trigger to illuminate this defective mentality: Gun sales have been extremely robust during Obama's presidency, as has been the rhetoric and fear mongering of some very popular Conservative talking heads and Right-Wing media outlets suggesting Obama plans to take guns out of the hands of law-abiding American citizens.

http://www.thetruthaboutguns.com/2016/03/dean-weingarten/2016-shaping-up-to-be-biggest-gun-sales-year-on-record/


http://blogs.lse.ac.uk/usappblog/2016/06/02/why-are-there-more-and-more-guns-in-america-blame-fox-news/

I'll close out by admitting this is not a TGDT story...sorry for contributing to the OT. Perhaps there should be a TNPH board (National Paranoia talking-Head wind) :)

It's similar to pundits and politicians reiterating and persuading everyone how horrible everything is right now, i.e., how poorly the democrats have done in the executive office, yet the unemployment rate has gone dramatically down for the last 8 years, and the stock market is at an all-time high. I'm sure they, their fans and constituents are pretty content with those aspects of their lives. But I'll bet they feel they deserve all the credit for that, and not macroeconomic policy. Talk about intellectually shallow...

While it is common sense that tax laws and preparations were more straightforward than they are now, you are citing stories from 22 and 23 years ago re Bill's briefs. Or were they boxers ??

I'll classify that as a funny anecdote, but on a serious note, one has to wonder what is going on with Trump's taxes. I'm sure there are more stains in one tax year than there are in all Bill's undies combined. Nobody is more full of crap than Trump. Sorry to get carried away with the metaphors...

Am I missing something? It is one thing to disagree with the man's business practices and politics, but Satan? Really?

http://givingpledge.org/Content/media/My%20Philanthropic%20Pledge.pdf

Thank you. I'll be as cautious as I should be with a small bio stock. I am having trouble accepting the certainty of a patent infringement with CaPre though, as many of you guys suggest. Amarin overcame a lot of patent concerns and regulatory hurdles to get where they are...not bad by the way...congrats to all you longs. I'm comfortable, at this point, with the little dog chasing the big dog's tale: The big dog is fat from too much fish! :)

Neptune has a long history of manufacturing krill, has many patents in their own right, and has won several international patent disputes in the last few years to defend their business. Yes, the science is light at this point, but there is not much reason to believe it won't be deepening soon. Everything is new/young early on, yes? Just because there isn't much evidence does not mean it doesn't work as good as, or even better, than Vascepa or Lovaza. We shall see in a few years.

Sure...they can skate thru like Amarin with their single phase-3 Marine trial and an SPA agreement with the FDA :) Of course nothing, particularly a Ph3 trial, is that easy, so skate might have been a poor choice of words. On the other hand...we're talking fish oil dude -- nothing earth-shattering or highly innovative, as opposed to many other drugs that have gone all the way.

Considering they invoked the 505(b)(2) NDA pathway, they were able to save time and money. Hopefully, they can do the same with Ph3 (save time and money, like Amarin).

Speaking of money, I would fully expect them to do a raise at some point in the near future. They are also 48% owned by NEPT, a large krill producer, so they can make things happen at that end also.

By all means, though, short it, I'm sure at some point it will be a good idea. I'm not in love with the stock(s), so I'm ready to pull the trigger in stages should things work my way. I am, however, a believer in good fish oil...NKO extract to be exact.

Thanks. I wouldn't discount the product (or threat) too much though. They are going after the same RX market as Vascepa too. They are a spin-off of the krill supplier Neptune Bioressources (now a subsidiary of). Capre most certainly does not resemble the OTC krill products, in strength, from which it is derived: it is a purified and concentrated formulation, probably not much different than Vascepa. I would imagine they did not reveal the EPA/DHA %'s because they didn't have to.

Stock(s) (ACST/NEPT) have been slow to react, although ACST is showing a large volume spike and steadily moving up, and NEPT is just waking up. The muted response is not surprising...these guys have been off the radar for a long while. More opportunity to load up :)

Any thoughts on the time frame to skate through a phase 3, and also the potential impact to AMRN?

Acasti Pharma Reports Positive CaPre Omega-3 Bridging Study Data

http://finance.yahoo.com/news/acasti-pharma-reports-positive-capre-120000754.html

Marketwired September 14, 2016

LAVAL, QUEBEC--(Marketwired - Sep 14, 2016) - Acasti Pharma (ACST)(TSX VENTURE:APO) today announced that its bridging study for novel drug candidate CaPre® (omega-3 phospholipid) has successfully met its objectives, supporting Acasti's strategy to pursue the U.S. Food and Drug Administration's (FDA) 505(b)(2) regulatory pathway for approval. Acasti is developing CaPre for the treatment of patients with severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. The 505(b)(2) regulatory pathway allows Acasti to streamline the overall development program required to support a New Drug Application (NDA) by relying on the safety data of an approved drug.

"We are confident that the results of this study support the 505(b)(2) regulatory pathway chosen by Acasti to gain marketing approval of CaPre," said Jan D'Alvise, president and CEO of Acasti Pharma. "With this momentum, we look forward to working with the FDA to confirm the pathway and optimize the design of our Phase 3 program, which will seek to demonstrate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia."

Acasti's open-label, randomized, four-way, cross-over, bioavailability study compared CaPre given as a single dose of 4 grams in fasting and fed states with the approved hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters) in 56 healthy volunteers. The study met its primary objective and demonstrated that the levels of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) following administration of CaPre did not exceed the levels following administration of LOVAZA in subjects who were fed a high-fat meal. These results support the basis for claiming a comparable safety profile of the two products.

Furthermore, among subjects in the fasting state, CaPre demonstrated better bioavailability than LOVAZA, as measured by blood levels of EPA and DHA. As previously reported, the bioavailability of CaPre is not significantly reduced when taken with a low-fat meal versus a high-fat meal. This could represent a significant clinical advantage for CaPre since the administration with a low-fat meal represents a more attractive regimen for patients with hypertriglyceridemia who follow a restricted diet.

CaPre is a novel composition of omega-3 phospholipids sourced from krill. Its omega-3s, principally EPA and DHA, are naturally either "free" or bound to phospholipids that help them to be better absorbed into the body. This allows for enhanced bioavailability and EPA and DHA blood levels compared to the "esterified" fish-oil omega-3 options such as LOVAZA. CaPre is designed to modulate the major lipids associated with cardio-metabolic disease: in two previously reported Phase 2 clinical trials, CaPre reduced triglyceride levels, lowered non-high density lipoprotein (non-HDL-C, a useful marker of cardiovascular disease), and increased levels of high density lipoprotein (HDL-C, or "good cholesterol") while having a neutral to positive effect on lowering low density lipoprotein (LDL-C, or "bad cholesterol").

"The CaPre bioavailability study has reinforced the compound's unique attributes in comparison with the leading pharmaceutical agent for hypertriglyceridemia," said Roderick Carter, M.D., chairman of Acasti Pharma. "CaPre demonstrates clinically meaningful effects on many key markers of cardio-metabolic health. With high rates of obesity and diabetes fueling the number of patients with elevated triglycerides and cholesterols, CaPre could fill the need for a best-in-class omega-3 medication that addresses the full lipid profiles of these patients."

About CaPre

Sourced from krill oil, CaPre seeks to provide a full scope of health benefits to patients with hypertriglyceridemia, filling a medical need that no other omega-3 treatment option has been able to address. CaPre successfully completed Phase 2 clinical trials for the treatment of hypertriglyceridemia, a very common metabolic condition in which blood levels of triglycerides, a type of lipid, are elevated, posing a risk to cardiovascular health. Severe hypertriglyceridemia, affecting more than 4 million adults in the U.S. is associated with an increased risk of coronary artery disease and pancreatitis and is often caused or exacerbated by uncontrolled diabetes mellitus, obesity and sedentary habits. CaPre is intended to be taken orally once per day in capsule form.