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no not true, I keep getting emails and phone calls to loan my shares by the brokerages. The shorts are doomed! They have run out of time. I woudn't be surprised they change their tune if not today may be tomorrow. FOMO is real.
Shorts are working harder today though they know they are doomed.
Time Has Run Out For Shorts
so you are saying senti and flipper know much better than the board who were building the Company?? I do like senti and flipper and enjoy their contributions to this board and do you think they appreciate your revolt? Don't be too smart.
Looking4aprofit/Lykiri, I thought about the effectiveness of our DcVaxL vaccine when everything TLD is revealed and a paper published and so forth. I would say DcVaxL is effective 99% for IDH wild type if we start early at stage 1 while it sure cures 50% for mesencymal stage 4 patients who were tested in the trial I believe. I think it is pretty common that no vaccine including all these Covid vaccines are not 100% effective. So what I am trying to say is that we can be proud of one of the long investors of a cancer vaccine which is effective to a significant percentage in curing cancer.
https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11507:delta%20variant%20pfizer%20vaccine%20efficacy:sem.ga:p:RG:GM:gen:PTN:FY21
see this is what NWBO do to you now. You became a philosopher instead of who you are. Hope it doesn't go further down the slope t plucking you hair and wander around the street.
No worries. They are just copycats. Checkpoints as monotherapy failed in GBM - flipper told us. Longfellow told us how deadly they are in some patients. They have been trying to circumvent ever since DcVaxL arrived like 15 yrs or so before; still we are here - no ime is of essence except lining up the ducks in a row; almost done.
scotty booty, manufacturning GMP cert might include Flaskworks; all in one strike, how abut that? Get ready to look for your rear.
FDA seems pretty busy after reviewing the deadly side efects of their blood cancer drug, FDA still went ahead and lifted the hold; and the stock soars. Aren't we soar back to $12 after 6 yrs?? The time is ripe and of course long overdue to much more than $12. Go NWBO!
https://www.marketwatch.com/story/protagonist-therapeutics-shares-soar-after-fda-lifts-clinical-hold-on-its-experimental-cancer-drug-2021-10-11?mod=mw_latestnews
Lykiri/pgsd, do you think LP is going for a grand cert from MHRA that includes Flaskworks too?? The Company said they would be ready testing the Flaskworks by the summer, if I am not remembering right.
yep, I can't wait to see a short squeeze coming; last hr today could be inerestinggg
yep perfect symmetry for a huuuuge W
CDEL and NITE can manipulate all they want; but do you trust them? The shorts think these MM thugs are helping them harvesting short profits. But they are there for their own game: mostly for volume play like securedinvest preach us. When the stock jumps, these MMs move forward trumpeting northbound. The shorts are left with nothing that time. No 20million share nothing; you are a gypsy fudster.
wish the thugs do a mini bear raid today that I can coop some cheap shares.
page number please; sorry asking for more and more; I tried to look for it going over the pages though. TIA.
can u share the link please, very interesting. It is not misbranding as they say not approved for commercial sale; carefully!
Exactly, straight shot that we don't know that - Dr. Sharpless said the same thing in that Braincancer Day talk he gave along with Dr. Pazdur. H said the change or the cancer cure is happening and can be coming all on a sudden. They are the regulators and it is their view. Who else is close to that kind of cutting edge results other than Northwest?? The shorts are really crazy and out of their rear these days. They better cover fast. No mercy on the naked shorts though.
yes agree they can't talk about it while the trial is still not unblinded. It is called MISBRANDING. FDA doesn't like it at all that they can kill the trial like they did it to one weightloss drug developer, I forgot the name. AF will be all over again like he colluded with the MDA Pakistani doc badmouthing before when Direct trial results were shared in advance or something. I see your point, thanks Viking!
great question! I think someone like Lykiri or sharpie or some UK longs can dig this number out from the 'Compassionate/Specials Program' sites in the Europe if it is something evn FOIAd there. Really a very good question. The way patients are lined up for the vaccine on the waiting list for 6 to 12 months avg 50 a month in the Europe tells me clearly the patients know the vaccine is working. Otherwise why such a huge demand?
Irrespective of the waiting on the Cert, why are we lingering around 1.20? We should be hovering past the 2.60 the previous 52W high, once we saw the FDA officials support the EC concept in the Lancet paper; it is like we got our USA clinicaltrial registry updated already with our new 6 endpoints; don't you think so FeMike? With the new endpoints accepted, meeting the primary endpoints is no big deal - everyone who follows this stock/Company knows that; don't you agree FeMike? In other words, it is like the Germany and UK RAs approved the new endpoints in their clinicalregistry and when ATL leaked this info, the pps rocket to 2.50+. What is the difference now when Amy and Kayani supported the EC controls?? The shorts are in a big surprise, don't you think so FeMike?
I meant 'now' not 'not'; sorry.
with that external control paper published in the Lancet, shareholders are no more nervous about our new endpoints; in the past there was a fear whether those will be accepted by the RAs for review; but not anymore after seeing that approach was in fact supported by the FDA officials like Amy and Kalyani who were duly acknowledged. Con master AF even tried a few days before calling the trial failed; but thanks to the Lancet paper, he couldn't crash the stock price with such a lie. Longs are not staying very comfortable like jed said and can wait any longer as LP gets us and the patients what we want. Agree Sawston cert comes any minute now. Are there any con master master than AF out there?? No sledgehammer can stop this train anymore.
north, do you still hold TSOI? bought at 12c when you spoke last time; it trades ~5c now. Is it still good to add and average? After MRK's covid pill, TSOI is going down as can be no covid interest anymore, imo.
or Monday news means the call is already answered well. I too think we get news by Monday before 9.30 am the call time. At least we might hear the Sawston cert I believe. Otherwise why all on a sudden now DI is out from the year long Quiet Period so open scheduling calls with both hands left and right. I think something is up for sure.
We are the King in the solid tumor cell therapy field with no safety issue. FDA put a hold on ALLO; Look at Chang's ALLO drops 40% as its CAR-T cell therapy as its single lymphoma patient developed chromosomal abnormality
https://theworldstockmarkets.com/index.php/2021/10/08/allogene-therapeutics-stock-drops-as-much-as-40-as-fda-puts-hold-on-cancer-drug-study/
where is that fake 1.19 wall gone now? These thugs are simply fooling themselves as no long is falling for their game. They will have to cover fast for sure. But no mercy from us.
and flipper look at the clinicaltrial registry for the completion date of this combo trial somewhere into 2025. I think Merck wants to sell its Keytruda until its patent expires in 2018 or LP wants to sell her DcVaxL as an monotherapy after surgery for tens of years or so and then into generating revenue selling combo.
Yes it is She LP! How did she get to position in the middle?? That crowd already gave her that space. Wow!
yep that is what I meant. Thanks for helping me.
Absolutely; the combo therapy is a new patent and thus Keytruda gets extension, I am sure about it.
I think the blood pr drug is still in the development stage, not even in phase 3, but MRK is ok to pay ~12B for this and a blood cancer drug sharing revenues with BMY. Agree we should get more as DcVax platforms L and D cover all solid cancers, a trillion dollar industry.
Looks like molnupiravir is problematic not without risk or toxicity; it should be tested for mutations. It can cause cancer?? Someone has to com up with a Covid pill to cure covid patients like we have DcVaxl for curing cancer.
DcvaxL is the best with no side effects.
Why Merck's covid pill could be riskier than people think---from Barron's.
Why Merck’s Celebrated Covid Pill Could Be Riskier Than People Think
By Josh Nathan-Kazis
Updated Oct. 5, 2021 8:50 am ET / Original Oct. 5, 2021 4:30 am ET
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Merck's Covid-19 antiviral pill molnupiravir
Merck ‘s announcement that its antiviral molnupiravir had halved hospitalizations in a trial of high-risk Covid-19 patients was met with enthusiasm on Friday, inspiring a vision of a world in which treating a Covid-19 infection could be as trivial as swallowing a few pills.
Some scientists who have studied the drug warn, however, that the method it uses to kill the virus that causes Covid-19 carries potential dangers that could limit the drug’s usefulness.
Molnupiravir works by incorporating itself into the genetic material of the virus, and then causing a huge number of mutations as the virus replicates, effectively killing it. In some lab tests, the drug has also shown the ability to integrate into the genetic material of mammalian cells, causing mutations as those cells replicate.
If that were to happen in the cells of a patient being treated with molnupiravir, it could theoretically lead to cancer or birth defects.
Merck (ticker: MRK) says it has run extensive tests in animals that show that this isn’t an issue. “The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in-vivo mammalian systems,” a Merck spokesperson said.
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Scientists who have studied NHC, the compound that molnupiravir creates in the body after it is ingested, however, say that Merck needs to be careful.
“Proceed with caution and at your own peril,” wrote Raymond Schinazi, a professor of pediatrics and the director of the division of biochemical pharmacology at the Emory University School of Medicine, who has studied NHC for decades, in an email to Barron’s.
Scientists are split on how serious a risk this is, and in the absence of detailed data on Merck’s animal tests, and long-term human safety data, it’s difficult to know for sure.
The safety concerns suggest that the stock market’s reaction to the positive molnupiravir data on Friday might have been overblown. Shares of Merck jumped 8.4% Friday, while shares of Covid-19 vaccine maker Moderna (MNRA) fell 11.4%, and shares of Regeneron Pharmaceuticals (REGN), which developed one of the leading monoclonal antibodies for Covid-19, fell 5.7%. Vir Biotechnology (VIR), which developed another of the monoclonal antibodies in partnership with GlaxoSmithKline (GSK), was down 21.1%.
“It was sort of, in effect, wishful thinking,” says SVB Leerink analyst Dr. Geoffrey Porges of investors’ reactions on Friday.
Investors saw Merck’s pill as a pandemic panacea that would sit in everyone’s medicine cabinet, he says, adding, “that’s just not going to be the case with this drug.”
Porges says that when the Food and Drug Administration authorizes molnupiravir, he expects regulators to impose severe limitations on who can use it. The agency, he says, will have difficult questions to answer about what conditions to put on access for people who may become pregnant. “I think it is effectively going to be a controlled substance,” he says.
Porges later clarified his comment, saying that he expects that distribution and access to molnupiravir will be limited, not that it will be treated as a “controlled substance” under U.S. law, as are some addictive and illicit drugs.
Molnupiravir came to Merck through a partnership with a private firm called Ridgeback Biotherapeutics, which licensed the drug from a not-for-profit biotech concern owned by Emory University. Molnupiravir is what’s known as a prodrug, which metabolizes in the body to create NHC, which has been studied for decades.
Schinazi, who is a professor at Emory but did not work on molnupiravir, has a long history with NHC, and has written a number of papers on the compound. He was a founder of the biotech Pharmasset, which he says considered developing NHC as a treatment for hepatitis C in 2003, but chose not to because of the risk that it could cause mutations. Pharmasset created the hepatitis C drug Sovaldi, and Gilead Sciences (GILD) eventually bought the company for $11 billion.
Schinazi told Barron’s that he did not believe that molnupiravir should be given to pregnant women, or to young people of reproductive age, until more data is available. Merck’s trials of molnupiravir have excluded pregnant women; the scientists running the trial asked male participants to “abstain from heterosexual intercourse” while taking the drug, according to the federal government website that tracks clinical trials.
A paper published in the Journal of Infectious Diseases in May by Schinazi and scientists at the University of North Carolina reported that NHC caused mutations in animal cell cultures in a lab test designed to detect such mutations.
“The risks for the host may not be zero,” the authors concluded. “Evaluating the utility of this drug should be done in those likely to receive the greatest benefit, with monitoring provided to assess potential long-term genotoxic side effects.”
One of the paper’s authors, Dr. Shuntai Zhou, a scientist at the Swanstrom Lab at UNC, said that he and his colleagues had flagged their initial findings to Merck in July 2020, roughly a year before his paper was published.
“There is a concern that this will cause long-term mutation effects, even cancer,” Zhou says.
Zhou says that he is certain that the drug will integrate itself into the DNA of mammalian hosts. “Biochemistry won’t lie,” he says. “This drug will be incorporated in the DNA.”
What impact it will have when it’s there is unknown, given the various systems human cells use to limit the impact of mutations.
Merck scientists responded to the UNC paper in a subsequent issue of the Journal of Infectious Disease, saying that their tests of molnupiravir in animals had not found higher mutation rates. The Merck scientists also took issue with details of the UNC authors’ methods. In a reply, the UNC scientists stood by their methods, and wrote that they believed that molnupiravir should only be used in people at high risk of serious illness from Covid-19 until its long-term risks are better understood.
Some experts have advised caution on the part of Merck and regulators.
“Given the possibility that the drug could be incorporated into cellular DNA, it will be very important to demonstrate a lack of cancer in animal models and in humans,” says Nathaniel Landau, a professor in the department of microbiology at the NYU Grossman School of Medicine who is not involved in any of the NHC or molnupiravir research. “Even though it looks good in preliminary animal models, it will be important not to rush this into clinical use before being very confident that it does not cause cancer even at very low frequencies.”
Molnupiravir’s first brush with public attention, long before Merck began its collaboration with Ridgeback, came in May 2020, when the former head of the U.S. government’s Biomedical Advanced Research and Development Authority said in a whistleblower complaint that he had been pressured to provide funding for molnupiravir, then known as EIDD-2801, but had objected, partially due to safety concerns. The former BARDA head, Dr. Rick Bright, told Bloomberg this past March that the involvement of Merck had “softened” his concerns.
Indeed, Merck’s reputation for rigor has eased some observers’ worries. SVB Leerink analyst Daina Graybosch notes that the data on molnupiravir released last week came far later than some investors had expected. “Merck took a really long time to develop this,” Graybosch says. “They haven’t necessarily said this explicitly…but I think they’ve been doing a lot of work to get comfortable around this risk.”
Graybosch, who covers Merck for SVB Leerink, raised her target price on the stock on Monday, to $104 from $101. Still, her outlook on molnupiraver is muted. “The continued halo effect provided by molnupiravir in the eyes of the public and investors could be more impactful than its direct effect on P&L [Merck’s profit and loss statement],” she wrote in a Monday note.
Merck said it ran two separate tests in animals in which it gave monulpiravir at higher doses, and for longer, than it would in humans. The tests showed that monulpiravir is not mutagenic, the company said.
“Patient safety is at the forefront of our company’s joint mission and vision: to save and improve lives,” Merck said in a statement to Barron’s. “Our top priority is to ensure the safety of the patients who receive our drugs and vaccines. In everything we do—from research and development to the manufacturing and distribution of our medicines, vaccines and other products—safety, quality and efficacy are our primary considerations.”
Merck shares closed up 2.2% Monday, while Moderna shares fell another 4.5%, and Vir shares dropped another 0.8% on the day.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com