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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.
RespireRx Pharmaceuticals Inc. Announces Preliminary Top-Line Analysis of Data From Duke University Phase 2A Clinical Trial of CX1739
Marketwired September 12, 2016
GLEN ROCK, NJ--(Marketwired - Sep 12, 2016) - RespireRx Pharmaceuticals Inc. ( OTCQB : RSPI ) ("RespireRx" or the "Company") is a leader in the development of medicines for respiratory disorders, including drug-induced respiratory depression (RD) and sleep apneas.
RespireRx is today reporting preliminary top-line data from its Phase 2A clinical trial of CX1739, the Company's proprietary, orally administered ampakine. CX1739 was determined to be safe and well tolerated, and antagonized the respiratory depressive effects of remifentanil (REMI), a potent opioid, in clinical models of acute opioid overdose and chronic opioid use. These results demonstrate target engagement of AMPA glutamate receptors and confirm the Company's translational approach to developing medicines for respiratory disorders.
The Duke University School of Medicine initiated this Company-funded Phase 2A clinical trial in March 2016. The dosing and data accumulation phase of the clinical trial was completed in June 2016 and the clinical trial was formally completed on July 11, 2016. Database unblinding occurred on September 7, 2016.
Study Design
The clinical trial, conducted in two separate stages over a four week period, was designed to assess the safety of CX1739, as well as its ability to antagonize the respiratory depressive effect of REMI without altering its analgesic properties.
Stage 1, a randomized, double-blind, crossover study comparing 300 mg of CX1739 to placebo, was considered a primary outcome study. After an overnight stay at the clinical facility, subjects were administered either placebo or CX1739. For the first visit, subjects were randomly administered either placebo or 300 mg CX1739. On the second visit, subjects were crossed over and administered the other compound.
Three hours after receiving placebo or CX1739, subjects underwent a REMI 1 period in which respiration was measured by impedance plethysmography for 5 minutes, in order to establish a baseline. Subjects then received an intravenous bolus injection of REMI (1 µg/kg) and respiration was measured for an additional 20 minutes after the bolus injections). During REMI 1, the primary measure used to determine antagonism of respiratory depression was the calculated time to recover (recovery time - RT) from the maximal respiratory depressant effects (Emax) of REMI.
Thirty minutes after the bolus injection of REMI, subjects underwent a REMI 2 period in which a continuous infusion protocol for REMI was begun (0.25 µg /kg bolus followed immediately by a constant infusion calculated to achieve blood levels of 2 ng/ml). After allowing 10 minutes for equilibration, respiratory rate, pain and pupilometry measurements were taken.
REMI 1 was designed as a model of acute opioid overdose, while REMI 2 was designed as a model of chronic, opioid consumption in which opioid blood levels remain relatively constant.
The clinical trial also evaluated the safety of CX1739 when taken alone and in conjunction with REMI and investigated the effect of CX1739 on the analgesic and sedative effects of REMI. These latter data have not yet been analyzed and will be reported at a future date.
Stage 2 took place during the second two week period and was designed as an open-label, ascending dose study to assess the ability of 600 and 900 mg of CX1739 to antagonize the respiratory depressive effects of REMI. Otherwise, Stage 2 was conducted in the same manner as Stage 1.
Safety and Study Conduct
Twenty-one subjects initially were enrolled in the study and all were included in the safety analysis. Four subjects terminated early, two because of scheduling problems and two because of adverse events (AEs). Of the 17 subjects who completed the study, two did not display maximal depression of respiration rate (Emax) >25% and were not included in the respiratory data analyses.
In general, CX1739 was safe and well tolerated, and no serious adverse events (SAEs) occurred. By far, the most frequent AEs were nausea, vomiting, headache and dizziness, all of which are common side effects of opioids. Forty-nine AEs were reported by 15 of the 21 subjects. Thirty-nine AEs occurred after the administration of REMI and 8 AEs occurred less than one hour after ampakine or placebo administration, a time period that is too early for significant blood levels of CX1739 to have occurred.
Efficacy Measures
REMI 1. Acute bolus injection of REMI caused a rapid and dramatic decline in respiration, with Emax ranging from 15% - 100% across subjects. When subjects in Stage 1 were pre-treated with 300 mg of CX1739, a statistically significant reduction of RT, the primary outcome measure, was observed. RT was reduced from a mean of 6.8+ 0.98 after placebo pre-treatment to a mean of 4.4+0.77 after 300 mg of CX1739 pre-treatment (p=.01, paired t test). In Stage 2, RT was reduced for both doses, although no significant differences (p>.05) were observed when these doses were compared to either placebo or 300 mg. While this difference between 300 mg and the higher doses might reflect greater efficacy at the 300 mg dose, the Company believes that this lack of significance for the higher doses might also reflect inter-subject variability in what doses produced the optimum decline in RT. Supporting this idea, responder analysis revealed that decreases in RT were observed, in a statistically significant proportion of subjects (13 out of 15, p<.005, z test), after one or more doses of CX1739. Using these data from optimum doses, mean RT was significantly (p<.002, paired t test) reduced from 6.8 +0.98 minutes after placebo to 3.7 +0.70 minutes after CX1739.
REMI 2. The REMI 2 period began 30 minutes after the REMI 1 bolus injection of REMI and in this case was a continuous intravenous infusion. Baseline respiration was recorded during the first 2 minutes. Ten minutes after REMI 2 began, when respiratory rates and presumably blood levels of REMI had stabilized, respiration was monitored continuously for 5 minutes and the average percentage change from baseline for the 5 minute interval was determined. The data from 5 subjects was excluded from analysis because the REMI produced less than 25% depression of respiratory rate when these subjects were pretreated with placebo. CX1739 produced a dose-related diminution in the respiratory depression produced by REMI, with statistically significant differences from placebo observed at 600 mg (p < 0.05, t test) and 900 mg (p = 0.01, t test).
Data regarding CX1739's ability to alter the opioid's analgesic properties have not yet been analyzed. A full statistical analysis is expected to be completed during October 2016 and a clinical study report is expected to be completed by the end of December 2016.
Conclusions
Having demonstrated proof of principle and target engagement, the Company has concluded that further development of CX1739 to determine its potential efficacy in the appropriate clinical indications is warranted, and future studies are being designed and planned.
I'm not sure what you are answering yes to, but I'm with you on a moral level. Two poor choices, lesser of two evils - we have to deal with what we have. Cross your fingers...
Yes, the world is a dangerous and anxious place nowadays. Yet, we ain't seen nothing yet, should a hater be America's 'leader'.
big differences between tobacco and oil: oil ain't addictive
Put me in the pro-Gøtzsche camp: Our relationship to prescription meds have become a silent epidemic. Psychotropic and mental health meds being the least reliable, short term and long term. Meds are consumed by individuals easier and with less thought than drinking tap water. Why? Because it is doc prescribed? The system has been corrupted on so many levels that, here included, so many have something to gain with the proliferation of the industry. Putting seniors with compromised cognitive abilities on psyche meds or the crappy alz meds we have is futile. Exercise and diet should come first. But very few will gain financially or feel they have time, thus prescriptions become the easy way out...the status quo if you will. Same with MOST ADHD meds. Shame on docs, parents (or adult children), and investors. Kudos Prof. Gøtzsche, that takes cojones!
GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex® (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome
http://finance.yahoo.com/news/gw-pharmaceuticals-announces-positive-phase-110000262.html
- Primary endpoint achieved with high statistical significance (p=0.0135) showing that Epidiolex treatment reduces drop seizures compared to placebo -
- Today’s LGS data follows successful Phase 3 trial in Dravet syndrome announced in March 2016 -
Redshirt Pharming
If there can only be ONE example of an epic fail in business, this would be a top candidate. Mullan only fueled the fire that was started prior to his taking over. The damage will never be reversed: you can't rebuild from ash.
Still making progress you say? At what cost? The cost will almost certainly be a total loss. Maybe we'll be able to cover our commissions on some good news, lol. But "lofty expectations", that's pure fantasy. Even if Abloc was a miracle drug, it couldn't dig Rock Creek out of the hole at this point.
WOW this is strikingly bad. And Mullan & Co's silence throughout this debacle is quite telling, so to speak. The red flags were all over this board for years, and I knew it! Makes me the biggest idiot of all, lol. At least the others who don't have anything negative to say about this heap of steamy manure don't have a clue. Ignorance is bliss...dream on and dream away. I guess the real question is whether or not it is better to be dumb, or foolish.
No matter, I wish y'all good people better days ahead. Bless ya'!
The implosion here is deafening. Does anybody else feel that pulling this off the market might have been the driving force? If abloc is as efficacious (and natural and safe) as has been attested to, why so willingly and indefinitely pull it from the users and believers? He has nothing to hang his hat on anymore...except many years of dragging and lagging trials and tens of millions of $'s drained from investors. Mullen might be a good scientist, but he's failed miserably as CEO; he's only facilitated the steady decline and has conveyed zero conviction to shareholders and business prospects.
I told myself, if the supplement gets pulled, get out. I should listen to my own convictions...but alas, I mostly hurt myself: not other people or other people's money. That is how I sleep at night.
How much is Mullen pulling down? 18% or so of the MC at this point? JW handed MM the keys to the Pinto, and we all know what happened next: he baja'd thru the tobacco fields of Virginia and North Carolina, and drove it to Sarasota and plowed it into the shareholders. Then, with all the value of the company in the hatch, he stepped out of the car, and simply watched, as the engine caught fire and burned the life out of the business.
Now, it's time for Mullen to pull a rabbit out of the hat: the one that no longer has a hook to hang on.
America's explosion of income inequality, in one amazing animated chart
http://www.latimes.com/business/hiltzik/la-fi-hiltzik-ft-graphic-20160320-snap-htmlstory.html
Why GW Pharma Could More Than Double From Cannabinoid Drugs
http://247wallst.com/healthcare-business/2016/03/21/why-gw-pharma-could-more-than-double-from-cannabinoid-drugs/
It is not normal to see the larger bulge bracket brokerage firms issue analyst price targets on stocks that imply upside of 100% or more. So, what are investors supposed to make of a Bank of America Merrill Lynch call that shows GW Pharmaceuticals PLC (NASDAQ: GWPH) being worth over 100% more than the current value?
GW Pharma was reiterated as Buy by Merrill Lynch’s Tazeen Ahmad. The firm’s prior $150.00 price objective was already north of 100% upside, given the $72.72 close from Friday. But now the price objective was raised to $172.00, at the top of all analyst call targets, for implied upside of some 136% if Merrill Lynch’s price objective comes to fruition.
Ahmad believes that the positive Dravet’s trial validates GW Pharma’s cannabis-based platform. Epidiolex achieved its primary endpoint of median reduction in seizure frequency in patients with Dravet Syndrome, and the higher rating is based on a higher chance of approval for Epidiolex in Dravet Syndrome.
While $172 is at the highest rung of analyst price targets, the Merrill Lynch report suggests that upside to its price objective may be drawn from positive data in another form of epilepsy, which may be seen in the second quarter of 2016. Merrill Lynch’s report said:
The study demonstrated a significant reduction in median seizure frequency (39%) vs placebo (13%, p=0.01). This trial was the first to study Epidiolex vs. PBO and we believe these results validate GW’s cannabisbased platform. … We increase our likelihood of approval in Dravet Syndrome to 60% (from 40%) and raise our price objective to $172.
Merrill Lynch said that Lennox-Gastaut Syndrome is another major catalyst, and the top-line study data is due mid-year. The studies have over-enrolled and data from the expanded access program released thus far showed higher efficacy rates in Lennox-Gastaut Syndrome relative to Dravet Syndrome response rates.
Merrill Lynch’s investment rationale is as follows:
We rate GWPH shares Buy. Our valuation is mainly driven by our view on Epidiolex, for which the company has presented positive proof of concept data. We see value in investing in GW based on the potential for a scientifically validated cannabinoid therapy to have wide utility over both orphan and non-orphan indications.
GW Pharma’s $72.72 close is within a 52-week range of $35.83 to $133.98, and the consensus analyst price target is $148.83.
By Jon C. Ogg
There was a time when a story like this elicited an exuberant response here. But because of the spineless, voiceless, incompetent management at the time (and the expert cheerleader who defended their failures time and time again -- waah, waah, it's the biotech industry's fault ), there would be no public spotlight or private infusion of funds to highlight and expedite the advancement of this potential game-changer in overdose treatment. The losers had a gift dropped square on their laps, but failed MISERABLY to do anything with it. It practically sold itself, lol!
Rapper DMX revived by Narcan — the opioid antidote that stops an overdose in its tracks
https://news.yahoo.com/rapper-dmx-revived-by-narcan%E2%80%94the-opioid-antitdote-that-stops-an-overdose-in-its-tracks-005115193.html;_ylt=A0LEVzW4Wr5WnZ8ALgRXNyoA;_ylu=X3oDMTEyYzlkZzBnBGNvbG8DYmYxBHBvcwMxBHZ0aWQDQjExNjBfMQRzZWMDc2M-
This week, rapper DMX became the latest person to survive a near-fatal overdose thanks to a lifesaving drug called Narcan.
The 45-year-old New Yorker, whose real name is Earl Simmons, collapsed in the parking lot of a Ramada Inn in Yonkers, N.Y., Monday night. According to the New York Post’s Page Six, which first reported the incident, by the time police arrived on the scene, Simmons was without a pulse and had stopped breathing.
A medic injected the rapper with Narcan, and he was reportedly brought back to semi-consciousness before being taken to a nearby hospital, where he stayed overnight.
Narcan, the brand name for the medication naloxone, is essentially an antidote to heroin and other opioid drugs. A full opioid antagonist, naloxone directly reverses the effects of opioids, such as respiratory depression. An overdose of opioids can result in complete cessation of breathing. When injected, naloxone can stop an opioid overdose in its tracks.
Though a spokesperson attributed the collapse to an asthma attack, a friend who’d witnessed the incident reportedly told Yonkers police that Simmons had passed out after taking some sort of “powdered drug.” It’s unclear what, exactly, Simmons might have consumed, but Narcan reacts only with opioids, meaning it would not successfully revive an unconscious person unless he had opiates in his system.
In the current heroin and prescription opioid epidemic, which has seen a 200 percent increase in the rate of opioid-related deaths since 2000, Narcan has emerged as a lifesaver.
Since it was first approved by the FDA in 1971, naloxone has become ubiquitous in hospitals and emergency rooms, and increasingly in ambulances and first-responder kits. Naloxone is included on the World Health Organization’s list of Essential Medicines needed for basic health care systems.
In recent years, many states have passed laws to expand access to Narcan as an overdose prevention measure. In order to encourage nonmedical professionals to act fast when a friend or loved one is experiencing an opioid overdose, many of these laws guarantee legal immunity for those who call 911 or administer naloxone themselves. (Absent such protection, someone who was with a drug user at the time could be arrested in connection with the overdose, or prosecuted or sued for administering unauthorized medical treatment.) According to the Network for Public Health Law, as a result of these so-called Good Samaritan laws “over 150,000 laypeople had received training and naloxone kits as of 2014, and naloxone program participants reported reversing 26,000 overdoses."
Nine states passed laws expanding access to naloxone in 2015, and as of September, all but seven states had passed their own Good Samaritan laws.
Around the same time, pharmaceutical chain CVS announced that naloxone would now be available without a prescription to CVS customers in 14 states, including Massachusetts and California. In March, that number will increase with the addition of Ohio.
And on Tuesday, Walgreens announced that it too would begin selling naloxone without a prescription at pharmacies in 35 states.
Schools in New York, Vermont, Delaware and Massachusetts have also begun stocking nurses’ offices with Narcan kits.
Dr. Elizabeth Drew is the medical director at Summit Behavioral Health, an addiction treatment center with locations in New Jersey, Massachusetts and Pennsylvania. Drew told Yahoo News that she thinks anyone who uses opiates, even by prescription, should also be supplied with Narcan.
“Even if you are prescribed an opiate and use it responsibly,” she said, there’s always a chance it could fall into the wrong hands and become deadly — especially if the person with the prescription lives with children or teens.
“Anybody who has opiates prescribed in the home should probably have this medication in the home,” she said.
This month, President Obama proposed $1.1 billion in federal funding to address the nation’s opioid epidemic. About $500 million of that would be dedicated to furthering existing efforts by the Department of Justice and the Department of Health and Human Services to implement overdose prevention programs at the state level, including expanding access to naloxone.
According to the White House fact sheet outlining Obama’s budget proposal, in the past year a toolkit released by the DOJ’s Bureau of Justice Assistance to help law enforcement agencies implement their own naloxone programs has been downloaded more than 2,200 times. The U.S. Department of Defense has committed to providing Narcan kits and training to all first responders on military bases, and the Substance Abuse and Mental Health Administration is dedicating $12 million in 2016 for states to “purchase naloxone, equip first responders with naloxone, and provide training on other overdose death prevention strategies.”
Drew noted that while increased access to Narcan is crucial to curbing the number of casualties caused by this epidemic, in terms of ending widespread heroin and opioid abuse, Narcan is “the equivalent of CPR.”
It may save lives, but Narcan cannot cure opioid addiction, nor can it prevent a second overdose. Drew said “open access to all types of care” — including abstinence-based support groups and medication-assisted treatment — is the key to overcoming the opioid epidemic.
But, she added, increasing access to Narcan nationwide is essential not only to save users from dying of an overdose, but also to raise awareness that heroin and opioid abuse “is a predominant problem in every one of our communities.”
“Now we can see this isn’t someone else’s problem,” Drew said. “It is all of our problem.”
I meant beneficiaries: those that may benefit from the product.
Exactly. It's not as simple as some people think. There is tremendous abuse in the market, for which the FDA must regulate for the health and safety of the public, but they also serve higher interests. Star may have been a target, but they could have legally maneuvered in a way to keep ABLOC on the shelves. But they didn't, and so the reason why they didn't becomes the resounding question. What interests are they serving primarily? I assure you, it was not the shareholders at the tIme, or the potential benefactors needs.
Nothing is that simple when business is involved, unless you want it to be.
Athletes and soldiers need anatabine for themselves and their friends, but the FDA won't let them have it.
I think this is on the order of the discovery of penicillin.
Fwiw - You stole my line, lol (#msg-119234673):
I was expecting the name to become Expire, with the ticker RIPC. Was ready to put the final nail in the coffin, lol.
Nostalgia: A year ago today...
OK Nomo you win I'm selling today.
I-Hub policy excerpt:
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Good post. Pretty much my sentiments, although I wouldn't necessarily put much stock in the fact that "someone is interested in keeping this company and science around"...as that can be said about many, many failed and failing biotechs. It doesn't signify much yet, except that they are definitely enriching themselves at the shareholders expense to keep this alive.
A nice read on the sociopath...
http://www.vanityfair.com/news/2015/12/martin-shkreli-pharmaceuticals-ceo-interview
I was expecting the name to become Expire, with the ticker RIPC. Was ready to put the final nail in the coffin, lol.
What demand? Got some realistic numbers? Would love to see them...
How could there be public outcry and public support for Abloc when it cannot be sold, bought or taken? Where is your logic there? Are they going to take Liefsmith's word for it? Do you think you speak for everyone that Abloc is the answer? Where is Couples and the other ambassadors? What does it tell you that they are silent? Connect the dots...it will take the exorbitantly expensive route of FDA approval for this synthesized fruit/vegetable/herbal compound to get back to the market. Silly, I know, because It Is as harmless as those very foods that contains it (and likely, just as effective, btw). The only other way is if the company itself decides to fight for the OTC supplement's return. Or until someone, anyone, can extract the molecule naturally.
Remember, certain fruits, vegetables, and herbs can also be very safe and powerful anti-inflammatories. And that HAS been proven.
Got any evidence?
No, only the delusionel can see the signicance of that piece of paper. Tell me, where is the clinical evidence showing anatabine's benefit on autism? The most you can hope for is that someday another company will roll the dice and Rock Creek can out-license the indication. It is not significant or important at this point -- it's just a distraction for you.
Love is blind, leif, love is blind.
Something for you to consider before you fall in love with a stock without much understanding or self-awareness of the whole picture:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=71330113
I'm the one creating distractions? lol
The science is not proven or credible enough, that is obvious based on the reflection of the company in its share price the last few years. I'm also not ridiculing the compound, just those that elevate it to a sort of 'holy grail' of medicine. It is not a joke that you are in love with a pill that no longer exists, and a company that has destroyed shareholder value. No joke there: that is all real (sad).
Think again before you accuse others of 'distractions', lol.
As I predicted, Maxim has supported the bid, stair-stepping this stock from the .70s right thru the .90s and on to its current level.
Leif, you are a hopeless romantic, and your love is a tiny pill made of a synthetic plant compound. Always remember that -- it's not true love.
Finally?
This is not "news". News is new: This was 15 months ago. The article is definitely more grounded than some of the nonsense posted on this board. That is the advantage of a reporter -- it strikes a good balance of bias, ie., a reporter with none, and a user/investor with nothing but bias. The reporter made the subject come off rational, lol.
So...would you call that an oversight on your part?
It didn't take long for your theory to implode, did it? Ouch!
Unfortunately, you are right. This is nothing but a pump and dump by Maxim. They were the sole placement agent for the toxic spiral debt financing. It should be illegal for them to play both sides like that. It is an obvious deception perpetrated on people/investors who clearly are emotionally impaired and intellectually compromised about these kind of situations. Very sad really. It is disgusting how people take advantage of the weak.
I think your intuition failed you here (#msg-111464286):
I have never accepted the vilification of J. Williams. I'd like to hear his side of the story (and then attempt to confirm it) first. I've had too much experience of decent people being convicted by an ignorant or malicious media to just accept everything I read.
Besides, let's talk about the what JW is doing now, not twenty years ago...That's really all I care to discuss.
Very interesting. Here is the 19 subject human study portion, including the exclusion and diet criteria (from your 2nd link):
EXPERIMENTAL PROCEDURES
Subjects
Experimental design and report were prepared following the CONSORT standards for randomized clinical trials where applicable. Available data from an ongoing pilot trial are presented. Subjects were recruited under protocols approved by the IRB (HS-12-00391) of the University of Southern California based on established inclusion (generally healthy adult volunteers, 18–70 years of age, BMI: 18.5 and up) and exclusion (any major medical condition and chronic diseases, mental illness, drug dependency, hormone replacement therapy [DHEA, estrogen, thyroid, testosterone], females who are pregnant or nursing, special dietary requirements or food allergies, alcohol dependency) criteria. All participants signed informed consent forms and were not offered financial compensation for participation. Subjects were allocated (based on stratified sampling for age and gender) into a control (n = 19) or experimental diet group (FMD, n = 19), followed by baseline examination. The control group continued normal food consumption and returned for a follow-up examination 3 months after enrollment. Subjects in the FMD cohort consumed the provided experimental diet consisting of 3 cycles of 5 continuous days of FMD followed by 25 days of normal food intake. During all three FMD cycles, study participants self-reported adverse effects following Common Terminology Criteria for Adverse Events. For the FMD group, follow-up examinations occurred before resuming normal food intake at the end of the first cycle (FMD) and also after 5–8 days of normal feeding following the end of the third diet cycle (FMD-RF). Pre-specified outcome measures include adherence to the dietary protocol and evaluation of physiological markers during and after completion of the study. Examinations included height, dressed weight, body composition (including whole-body fat, soft lean tissue, and bone mineral content) measured by dual-energy X-ray absorptiometry (DEXA), and blood draw through venipuncture. All data were collected at the USC Diabetes & Obesity Research Institute. Complete metabolic panels were assayed by the Clinical Laboratories at the Keck Medical Center of USC immediately following blood draw. Data analysis was performed independent of study design. Complete data will be made available elsewhere upon completion of the study.
Human Diet
The human fasting mimicking diet (FMD) program is a plant-based diet program designed to attain fasting-like effects while providing micronutrient nourishment (vitamins, minerals, etc.) and minimize the burden of fasting. It comprises proprietary vegetable-based soups, energy bars, energy drinks, chip snacks, chamomile flower tea, and a vegetable supplement formula tablet (Table S4). The human FMD diet consists of a 5 day regimen: day 1 of the diet supplies 1,090 kcal (10% protein, 56% fat, 34% carbohydrate), days 2–5 are identical in formulation and provide 725 kcal (9% protein, 44% fat, 47% carbohydrate)
Or maybe that is more false hope, born of desperation.
Agreed! eom