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Eggs in the face, but money in the pockets. Still an excellent deal.
Thank you for sharing. I see that APR has a delinquency tax note. Means for me they are dead. Gold Rush is alive but what is now after 4 years their relationship with us; in fact they are an independent company.
The valuation of APR is in my opinion without any foundation and 10 Mio ounce of Gold is a fake number. Totally unrealistically.
Thank you for reply.
These documents are in no way validating any size of resource. It could be any figure between 1$ and 10 Billion $.
We have no clue, but company paid 22 Mio$ for the resource. Based on what?
Based on these quotes, apart from the past data, the data have to be good otherwise, if bad, they would have to publish them as it would be material information.
Why is the share price under pressure when we have such convincing derisking info about the company?
Anyone who has an explanation for it? Thanks!
I tried to find some information about American Pacific Resources. Not much to find. Few articles about the acquisition of the company by PHI in fall 2017. No info if the deal ever materialized. No info about the deposit, e.g drilling results, sampling results- just nothing how they came to the conclusion that there are 10 Mio ounces of Gold.
Does anybody have info about the "mine" and its resources? Or is the mine a fake? Why is the company for 4 years "dead"?
We missed the chance to get Hahn as CEO. We should try to get Woodcrook. This would be the fastest path for approval.
We missed our chance to get Leronlimab approved within days:
BREAKING: Ex-FDA commish Stephen Hahn joins Flagship, a venture group that spawned Covid-19 vaccine maker Moderna
That revolving door between the FDA and industry is spinning even faster than usual.
Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars-- as the new CMO of its Preemptive Medicine and Health Security initiative.
Flagship confirmed the hire -- first reported in The Washington Post -- in a statement out late Monday.
“The importance of investing in innovation and preemptive medicine has never been more heightened,” said Hahn in a prepared statement. “In my career I have been a doctor and a researcher foremost and it is an honor to join Flagship Pioneering in its efforts to prioritize innovation, particularly in its Preemptive Medicine and Health Security Initiative. The more we can embrace a “what if …” approach the better we can support and protect the health and well-being of people here in the US and around the world.”
There’s nothing unusual about this. Scott Gottlieb wasted little time in making the leap to the board at Pfizer, grabbing a job that paid hundreds of thousands of dollars a year. And former FDA #2 Amy Abernethy just days ago joined former FDA commissioner Robert Califf at Google's Verily.
But occasionally consumer groups and politicians — then-presidential candidate Elizabeth Warren took a shot at Gottlieb — have attacked these switches between the agency and industry. And the Moderna OK is still fresh news, making this a likely flash point for the agency as critics pounce on the controversial aducanumab decision.
My experience over many years with many companies is that if Clay Trader appears on the scene shorters are not anymore far. Bad omen!
The days of Mrs Woodcrook are counted
OPINION
FDA's Janet Woodcock failed to stop the opioid epidemic
Drug manufacturers such as Purdue might have ignited the deadly opioid crisis. However, the FDA was instrumental in allowing the epidemic to play out.
Gerald Posner | Opinion contributor
When the Biden administration tapped Janet Woodcock as the acting commissioner of the Food and Drug Administration, it seemed a good pick. Woodcock had spent 23 years as chief of the Center for Drug Evaluation and Research, a unit the FDA describes as its “consumer watchdog" in America’s health care system. The CEDR is tasked with making certain that drugs are “safe and effective,” and “that the health benefits outweigh known risks.”
The administration made it clear that Woodcock’s interim role was an audition for the full-time position. “Six people familiar with the deliberations” told Politico that Woodcock is one of three on a shortlist, the others being ex-FDA Deputy Commissioner Joshua Sharfstein and current Deputy Commissioner Amy Abernethy.
Woodcock’s appointment, however, is a potential land mine for the new administration. The possibility she could be nominated as the permanent commissioner has sparked a firestorm among anti-opioid advocacy groups and victims of the opioid crisis. They charge that she was a central figure responsible for the FDA’s failure over a quarter-century to adequately control the opioid epidemic.
Dr. Andrew Kolodny, a senior scientist and medical director of Brandeis' Opioid Policy Research Collaborative, told me, “It’s no exaggeration to say that she presided over the worst medical regulatory failure in U.S. history.”
Allowing opioid epidemic to happen
During five years of reporting into a history of the American pharmaceutical industry, I discovered there was plenty of blame to go around in the opioid epidemic. Those culpable were not just pharmaceutical companies that aggressively promoted their addictive products, but also overprescribing doctors, multibillion dollar drug distributors who hid the high volume of orders to so-called pill mills and even national pharmacy chains, where secret bonuses prompted druggists to direct patients to higher profit narcotic painkillers.
I also came across evidence that the FDA was partly responsible for the epidemic. Unlike the others who were motivated by greed, the fault of the FDA was that it repeatedly failed to fulfil its role as the nation’s guardian of public health. Instead, the opioid crisis is filled with instances of the FDA’s timid enforcement, too easy approval of narcotic painkillers and regulatory decisions friendly to drug manufacturers. Some of its worst lapses were with Purdue Pharma and its blockbuster narcotic painkiller, OxyContin.
Janet Woodcock — often referred to as “the top drug cop” — had been in charge of CEDR for only a year in 1995 when the FDA considered approving OxyContin for sale to the public.
Purdue managed several significant victories. Despite safety studies demonstrating Oxy was safe for “short term” use, mostly severe end-of-life pain, the FDA approved Oxy for much broader treatment of chronic pain, everything from fibromyalgia to back pain. And while Purdue had not conducted any clinical trials to determine whether OxyContin was less likely to be addictive or abused than other opioid painkillers, the FDA allowed Purdue to claim on Oxy’s insert that its delayed absorption was “believed to reduce the abuse liability.” The drug’s label declared that addiction “is rare.” That freed Purdue’s marketing team to push their drug as much safer than any opioid competitor.
Janet Woodcock on June 14, 2011, in Silver Spring, Maryland.
Janet Woodcock on June 14, 2011, in Silver Spring, Maryland.
JOSE LUIS MAGANA/AP
Woodcock was still chief of the FDA’s watchdog group in 2001 when advocates argued for changes to OxyContin label to address the rapidly increasing rates of addiction and overdose. The FDA and Woodcock rebuffed most of the proposed reforms and instead approved mostly inconsequential changes to Oxy’s label. Victim’s groups had asked the FDA to rescind its endorsement of dispensing Oxy for chronic pain. Instead, the revised label said OxyContin was “for the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time.”
Former FDA Commissioner David Kessler contends that the “label change was a blank check.” The broad language resulted in billions in additional sales for Purdue.
As evidence poured in that opioid prescribing had exploded and that overdoses followed, the FDA hurriedly convened an advisory panel of 10 experts the following year and tasked them with recommending whether the agency should forbid dispensing opioids for chronic pain. There was no notice from Woodcock or the agency that Purdue had paid five of those panelists as consultants or through its speakers program. Three others had done similar work for other opioid manufacturers. Not surprisingly, the panel recommended no change in the FDA’s permissive labeling.
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Woodcock and the FDA then took six more years before they removed from Oxy’s label the claim that the risk of addiction was rare. The missteps regarding opioids continued unabated. In 2010, with Woodcock still at the helm of CEDR, Purdue won approval for a “new and improved” tamper-resistant OxyContin, although the agency’s own field tests demonstrated the new formulation had “no effect” in reducing abuse potential.
The following year, the FDA approved Endo Pharmaceutical’s Opana ER, an extended released opioid painkiller the manufacturer also touted as "tamper-resistant.” When ultimately the FDA was forced to request Endo pull Opana from the market, Woodcock admitted, “We determined that the product had dangerous unintended consequences.”
FDA's miserable failure
As the Opana debacle played out over several years, Woodcock oversaw the approval of a series of controversial opioid painkillers. An FDA advisory committee had voted 11-2 against approving Zohydro, a narcotic painkiller five to 10 times more powerful than Vicodin, Woodcock and the FDA instead pushed it through.
That prompted 29 state attorneys general and 40 medical and addiction experts to urge the FDA to reverse itself. Sen. Joe Manchin, D-Va., introduced a bill to compel the FDA to rescind its Zohydro approval.
Instead of backing down, Woodcock and her colleagues in the FDA leadership oversaw the agency’s approval in 2014 of Hysingla ER, a controversial successor to Opana. A year later, Woodcock and Sharon Hertz, the director of the FDA’s Division of Anesthesia, Analgesia, and Addiction, further broadened OxyContin’s indication to include children as young as 11.
A presidential Commission on Combating Drug Addiction and the Opioid Crisis concluded in 2017 that the FDA’s “inadequate oversight” had in part caused the nation’s opioid epidemic. This did not slow the FDA’s narcotic painkiller pipeline.
In 2018, it gave the controversial OK to Dsuvia, a sufentanil pill 10 times more powerful than fentanyl. This was despite the strong objection of Dr. Raeford Brown, an anesthesiologist who chaired the opioid advisory committee.
Brown later told the Guardian there was “a war” inside the FDA between those officials who had “failed to learn the lessons” about the deadly epidemic and those who had. In an unusually blunt assessment, Brown said the “FDA has learned nothing. … The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
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Brown joined Sidney Wolfe, founder of Public Citizen’s Health Research Group, calling for Woodcock to resign for her failure to implement National Academy of Sciences recommendations to improve the FDA’s approval and regulation of opioids.
Sens. Margaret Hassan, D-N.H., and Edward Markey, D-Mass., wrote to the FDA in 2019 asking for a “fuller accounting of its past decision-making processes for the approval and labeling of opioid drugs.”
Woodcock wrote a defensive and lengthy response claiming that the agency had always followed the letter of the law, and that the “FDA is fully committed to looking closely at the opioid crisis, learning from what happened, and identifying missed opportunities.”
Manufacturers such as Purdue might have ignited the deadly opioid crisis. However, to the families of victims, the FDA was instrumental in allowing the epidemic to play out.
Many of them are enraged by Woodcock’s appointment as the interim FDA chief. They would be devastaed, however, if Woodcock were to be nominated as the permanent commissioner. The Biden administration should avoid rewarding any government official who contributed to the opioid crisis having become the most lethal prescription drug epidemic in American history.
Gerald Posner is an investigative journalist whose latest book is "PHARMA: Greed, Lies, and the Poisoning of America." Follow him on Twitter: @geraldposner
I bought yesterday a small position (a few Million shares). The information which I have and found wasn't good enough to invest more. Could you please advise me where to find the best source of real and true information for this company? Thanks!
Not so happy Black- Ops. You forgot to name POL POT, former president of Combodia. He managed at least 1.5 Mio people. In this club she finds tough competition.
With money, you can buy everything!
Another issue:
Certain people here at the board claim all the wisdom for themselves.
We know very well we have failed to comply with the first endpoint P-Value - Law. One can discuss whether this law is meaningful or not - I personally think it is pure stupidity when applied only and exclusively as a decision criterion. Maybe it is necessary for bureaucrats who have limited IQ to make complex decisions. However, that is their rule. And we know it is not applied to all participants of the game.
Whatsoever, my view, and I think this is the view of many Longs, is that when a drug is safe as no one other which FDA has approved for COVID, and you see in segments huge benefits, then you can give EUA, while meantime you run a bigger trial to satisfy the p-value knights, e.g.in phase 4.
This is the only problem, for an SH.T p-value, FDA let ten- thousands people dye.
All come, don't worry!!
Why does BP win all the games in the USA? Look at the advisory board of your president. 70% directly or indirectly connected with Gilead or/and other BP. This is a fully corrupted system. How will it be in India? I assume the same! The difference? These billionaires have sat their "influencers" in the advisory board on the Indians president. MacLeod is immune to the USA and the Indian advisory board will listen to the money of Macleod and not from USA-BP.
I don't know, but I have been working with Indian and Indian cultures for years.
Here it comes! All as expected. A new kind of attack to get Leronlimab cheap in the hands of BP. Would I trust a CEO who comes from such a BP gang? Never! This new CEO will come with the mission to sell Leronlimabe to BP for a tiny price. Once you come from this gang, you got crooked. Never trust such a guy to do something honest and correct.
FDA Release - My takeaway:
I see 3 possible reasons why FDA released this unusual paper:
1) A honest interest to inform the public.
I consider this alternative, based on my observation of the last 5 years, as totally unrealistically. In addition, if the FDA had done this with good intentions, they would have released the "news" after market closing. It is obvious; their focus was on max. negative impact on share price
2) Reaction (Revenge) to the many emails, videos and questions by politicians.
I consider this variant also as not very probable as an institution like FDA will stand above all kinds of interventions and will not react to any provocations. Like Nader and CYDY, a small fish will not be able to challenge the big FDA at any time. They will not make the mistake to accept in public CYDY as an adequate counterpart and reacting in any way.
3) Fear about what is going on
I think this is the most probable reason why FDA attacked suddenly in public CYDY. All this talking about foreign countries didn't bother BP; they know at the end they have the world with their money under control. No Chiral, no Biomm gave them a headache. MacLeod, the big player in India, was and is the real game-changer. 100% private ownership by Billionaires. How do you bribe Billionaires? These self-made brothers want social prestige and this honour to get, like Gods, if they bring dead people to life with Leronlimab. Maybe they are really good people and want to help the people of their loved country. Indian are very proud people.
I believe the game for the Pharma Industry will be in India the same as in the USA. Money defines in India what local FDA will approve and what not. The big difference is that with MacLeod, CYDY sits suddenly indirectly on the other side of the table together with those people who define the rules of the game in India. FDA and BP recognized that they are losing their bad game, and CYDY will win.
This was the very desperate action of a cornered parties BP and FDA.
No doubt we will stay strong. I consider this release before closing the market as a desperate action of BP executed by the FDA. Last trial before earnings coming in from India and the Philippines.
FDA will not stop MacLeod; this company is in the private hands of 3 billionaire- brothers, which are real entrepreneurs. They can't buy them, but these 3 guys might have bigger plans with CYDY.
I am not worried at all. Corruption is the end of all countries, sooner or later.
Whatever FDA does, it is opening further loopholes and backdoors for BP. If you believe that this could be beneficial for our COVId tests, then sorry, you are a dreamer and haven't seen that there is no tiniest Good Will for Leronlimab. Why we have to go to Brazil? Philippines, India, Europe, Canada and UK?
Some of the posters here speculate that Gilead has more than 5% shares. No evidence so far was given.
MacLeod is owned by 3 brothers whereof one is worth 5 Bill $. If they approached CYDY and convinced about LL, they might now have started to buy-in. Maybe CYDY will be once an Indian driven company where these brothers have a substantial share.
Time will tell!
I wrote 7 months and 3 months ago in a personal mail to the Chief Medical Officer of EMA and send him all info about Leronlimab. The answer I got, "we observe, no approval yet from USA FDA". Don't expect anything from them. This is the same crooked club as FDA. Just making themselves important, but achieving nothing. Look how far behind Europe is with everything.
EMA is high political in their decisions. Even some Prime Ministers in Europe object to how they move according to politics. EMA will NOT take any decision which is not in line with FDA. Very sad!
Mitch was treated as the first patient on 14th of April. Plus 4 weeks plus one week for the others ends up with end of May. I guess the results we will see earliest end of this week.
Of course, Mitch knew after 2 days that he is back to the world and so will know the others already for at least 2 weeks, but I believe they will present everything first to FDA. Don't offend the FDA in Philippines right now. "Pvalue- USAFDA", I believe, will be soon shamed for their corruption. I hope a criminal investigation will be started after all.
I was live listening. In very short:
x) we had 2 parts of the show
x) 1. part with LL team (Nader, Recknor, Harrish)
x) all 3 made the parts very well. Of course, Recknor as a patient and as the doctor, was very good. Harrish explained very well the Covid- and LL actions.
x) 2. part with Nicolas, 1 add professor of Philippines and Mitch
x)Mitch was a patient, not in the hospital as they were full. He got advice via Zoom. He was down with o2 at 70 to 75%. 1st day after LL injection, he had 85% and 2nd day already 91%. Already on 1st day, he felt a substantial improvement in heart rate and other symptoms.
x) With EUA, I got confused. On one occasion, they said application on Monday (today) or Tuesday; initially, I understood that Nader provided several parts(188) to the FDA, but few have still to be supplied. Unfortunately, for not clear
x) confirmation of 100 vials per hospital allowed
x) once EUA was given, they will ship 200 000 vials to the Philippines
x) Nader said they have excellent progress with India; might come soon an announcement
x) Nader said again that IO- the application would be complete by June and awaiting a decision from Canada in July.
x) Nader didn't answer pricing will is 100% correct - he can't!
x) overall very positive promotion. The effect needs to be seen. I hope PR for EUA application (the Philippines come today or tomorrow)
I am following the advice of my best friend. I take every day D3, K2 and Zinc despite fully vaccinated. I took the experimental vaccine because I want to travel and if the RNA makes something wrong with my DNA, it will not matter so much, I am 68.
Anyway, I hope to buy soon LL in SEA; just in case.
Better 1000 000 000 vaccinated with 80% efficiency than 1000 000 with 90%.
This is a matter of time, distribution and money.
Or lock all the continents away from each other. Good solution like Australia? They locked the whole continent away for already over 14 months and almost no one vaccinated. This is the super solution? Australia became the new Alcatraz. All people in Sing Sing.
OK, lock away USA, BUT don't forget the borders to Mexico or Canada. Lock away whole South America?
No one is safe until all safe. Just pray your vaccination keeps you safe in your cave on our island.
All UN organisations fail in everything except collecting money in every way. WHO has just approved Sino vaccine - 1 year after first applications. If it goes after them, much more people would have died. I live currently in ME and I had many months ago the free choice out of 4 different vaccines, including Pfizer, Astra, Sputnik and Sinovac.
Good morning beaucrats of WHO; you deserve nothing, except disrespect.
How about FDA? We know, doing what the boss, who gives you 45% of your money you waste, wants. FDA even more dangerous than incompetent WHO.
Being loyal doesn't mean being stupid and also not being blind to shortcomings. In my 47 years working in the industry, I have had many bosses, low level and high level, and I have always been loyal to them, although I have not agreed all the time what they did with many of them. When the disagreement was too much, I talked with them; if it didn't change, and I didn't want to live with it, I changed the company.
During the 5 years with CYDY, I have disagreed with Nader's performance very often. I always had the choice to stay for a good reason or leave the CYDY investment behind me. I decided several times to stay. I respect Nader as a human being and as a CEO. I wrote him several emails on what I think he could do differently. Still, it shows, in my opinion, the poor character of those who call him publicly an incompetent and greedy idiot or whatsoever.
If you disagree, leave CYDY, but don't offend people and CEO who can not defend here on this platform. Write to him, get out of your anonymity. Stand to your opinion like a man (woman).
In that way, you will not change Nader, and you will not change the CEO of CYDY.
The management is not incompetent! Time will tell. When BP will recognize that they can't break the company they will adjust their strategy and seek to get at least a bite of the drug.
Nothing big comes in a short time. I will be here for another year and at this time the Pennysuckers will have been gone away with empty hands. This company's share price will be 3 digits, I have no doubts.
We have many Pennysuckers on this board trying to put sh.t on a company with the drug of the century.
Enemies who are trying to get this drug for cheap complaining for years about the drug. When this story got exhausted, they spread lies over the management. As this doesn't work, they come with fake lawyers with a cohort of shameless Pennysuckers.
No doubt, we all can have different opinions and views, but here should be not the place for permanent outrageous lies.
As you know , I reached out to Modi (to his personal email) and his direct offices guys. He got all information what is needed. I believe Indian government doesn't care how many are dying. It is like in all other countries, they care only on their pockets.
Wow....yes, mix Remdesivir with anything available and it will work better. This is not unusal for matters which doesnt work - as WHO says: "useless".
Misiu never gives up. She is just a little bit tired. Give her 1 day rest and she will be back.
I am very sorry that I made you busy with a joking reply to your joke.
12,65 $ by Thursday
Who is suffering? You? Me not. I know in which environment I live.
Just pray you are not getting deadly sick while Woodcrook is following her insane pvalue way. But if so, don't ask for leronlimab.
It is easy to talk about hunger when you have your daily full meals, it's easy to talk about idiotic p- value science while your healthy.
Take care, never get hungry or sick!
I run 40 years operation and know about the message of a pvalue but if you manage your operation only according pvalue you are tomorrow bankrupt.
Sir,very disappointing. Have you not yet recognised that USA gives to India Remdestodeath for free as a help? The government gives the sh.t away that nobody wants in USA and gives taxpayers money to the friends of Fraudci - Gilead. The game is a different. Not India gets help, but GILEAD gets taxpayer money. This is my view and my opinion.
Exactly my view and point. Everybody who is educated in this field will know what works and what is a waste of money. Sooner than later nobody will talk any more about Rmedesivir. I understand doctors need to be cautious despite they know what is working. Health is politically sensitive because of the money the system (politicians, hospitals and doctors) gets from BP.
They can give Remdesivir, it doesn't matter as every doctor meanwhile knows that it doesn't work. Even WHO says it's a waste of money.