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MM playing with emotion for Nov 21 ER. Best to buy on the dip after ER. Catalyst Phase 2 BL-8040 in combination with KEYTRUDA data to be release EOY.
Catalyst?
Preclincal data
Press Releases
November 2, 2017
BioLineRx Announces Oral Presentation at ASH of Data Supporting BL-8040 as Robust Mobilizer of Hematopoietic Stem Cells (HSC) Associated with Long-Term Engraftment.
http://www.biolinerx.com/default.asp?pageid=16&itemid=560
Midas, do you know the exact date and time that BLRX will be presenting at SITC in Nov??
Would you happen to know the exact date and time that BLRX would be presenting on NOV 8-12 SITC thanks.
FDA requires opioid makers to develop doctor training
U.S. regulators are requiring manufacturers of the most widely prescribed painkillers to provide extensive training to doctors in an attempt to stem the ongoing opioid addiction crisis.
Food and Drug Administration Commissioner Scott Gottlieb called the drugs a “potential gateway to addiction” in a blog post Thursday. He said the FDA this week notified 74 manufacturers of immediate-release opioids such as Vicodin and Percocet that their drugs will be subject to the requirements. Doctors would not be compelled to take part in the training.
About 2 million Americans are addicted to prescription opioids, and more than 15,000 died from overdoses involving prescription opioids in 2015.
Manufacturers of long-acting opioids such as OxyContin, which release their doses over 12 hours or more, have been subject to the requirements since 2012.
https://www.seattletimes.com/business/fda-requires-opioid-makers-to-develop-doctor-training/
PTC Therapeutics Duchenne drug may work, data inconclusive: FDA panel
PTC Therapeutics Inc's experimental drug to treat Duchenne muscular dystrophy, a devastating degenerative disease that mostly affects young boys, may work but the company will need to do more work to prove it, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.
https://www.yahoo.com/news/fda-panel-ptc-therapeutics-duchenne-drug-data-inconclusive-200722290--finance.html
Opioid commission unveils new partnerships, drug supply limits to stop epidemic
New Jersey Governor Chris Christie held the third formal meeting of President Trump's ongoing Commission on Combatting Drug Addiction and Opioid Crisis, where officials in the pharmaceutical industry and government detailed new partnerships and efforts in the hopes of limiting the use of opioid prescriptions for combatting pain and recommending new treatments for pain management without the use of addictive substances.
National Institutes of Health Director Dr. Francis Collins advised the commission that the agency is looking to build partnerships with researchers across academia, government, prescribers and patients to "cut in half the time needed to make available prescriptions that are non-addictive."
He said areas like developing "potent but non-addictive drugs" for pain relief and offering new avenues for treatment would become a top priority for the partnership.
Collins noted that similar efforts have been taken on by NIH with regard to both Alzheimer's and Parkinson's Disease and said the body "can do the same with opioids."
PhRMA CEO Stephen J. Ubl also announced another significant step in the effort to curb the abuse of opioid prescriptions, telling the commission that the company will support limiting the supply of opioids to 7 days, as opposed to the traditional 30-day supply for short-term pain management and minor treatments.
"Over-prescribing can lead to excess pills falling into the wrong hands," said Ubl. He added, "given scope of this crisis, we believe it's the right thing to do."
https://www.cbsnews.com/news/opioid-commission-unveils-new-partnerships-drug-supply-limits-to-stop-epidemic/
Comments cbli vs psti advantage who??
CBLI Nuclear Radiation Treatment."partially funded the Russian Federation Ministry of Industry(“ MPT ”)". 3.7M FLOAT. Potential contracts w/Governments. Market cap really a joke vs The market for medical radiation countermeasures. Received Europe Orphan Drug Status For Acute Radiation Syndrome Treatment.
Company has much better balance sheet in 2017. expenses reduced about $12m in 2016 vs 2015. As of December 31, 2016, the Co. had $15.2m in cash.
from 10-K:
"We believe that entolimod is the most efficacious medical radiation countermeasure currently in development".
"Entolimod is a Toll-like receptor 5 (" TLR5 ") agonist, which we are developing as a radiation countermeasure for prevention of death from Acute Radiation Syndrome (" ARS "), and as an oncology drug. We believe that entolimod is the most efficacious medical radiation countermeasure currently in development. Following is a summary of the clinical development of entolimod to date and regulatory status"
"The market for medical radiation countermeasures grew dramatically following the September 11, 2001 terrorist attacks and the subsequent use of anthrax in a biological attack in the U.S. Terrorist activities worldwide have continued in the intervening years and the possibility of chemical, biological, radiation and nuclear attacks continues to represent a perceived threat for governments world-wide. In addition to the U.S. government, which maintains a national stockpile of products for emergency use (the " National Stockpile "), we believe the potential markets for the sale of radiation countermeasures include U.S. federal, state and local governments, including defense and public health agencies; foreign governments; non-governmental organizations; multinational corporations; transportation and security companies; healthcare providers; and, nuclear power facilities"..
Third time listing to the webcast and I am reminded about a poster I read a long time ago at a company that I use to work for about CEO's language and wordings. It stated somewhere alone these lines "the reputation of the company at that very moment in time is more important then the end result because humans behavior are involve therefore failure is an option."
Dr. Susanne Wilke and Dr. Daniel Alkon are putting their reputation on the line. Dr. Wilke makes this statement TWELVE times "WE BELIEVE!!" and she also has the nerve to mention twice "WHY WE BELIEVE WE HAVE A PARADIGM SHIFTING" WHAT A BOLD DECLARATION!
And Dr. Alkon start using words affirmation like, we also SHOW, we could SEE, ACTUALLY increasing, ACTUALLY measuring, we have SHOWN, we SAW major reversal, sporadic etc. and then he tells us that the industry has been mislead. What a slap to their face if he is right.
I also like when his tone change a little and he started to declare aggressively ApoE3 and ApoE4 confirmation at 14:20.
Putting their reputation on the line. I don't know about you guys but to make those bold statement they know.
https://www.veracast.com/webcasts/bio/ceoinvestor2017/18111483071.cfm
I agree, I just wanted to show how his bluff was called by Michael.
Michael Bigger @biggercapital
Added $NTRP calls
10:30 AM - 28 Apr 2017
Adam Feuerstein ? @adamfeuerstein
@ty17rr @biggercapital @measured_moves Well, @biggercapital is a prodigious promoter of $NTRP so seems relevant to know if he's selling stock at same time
Michael Bigger @biggercapital
Added $NTRP calls
10:30 AM - 28 Apr 2017
Toddler with 'childhood Alzheimer's' symptoms gets experimental treatment
https://gma.yahoo.com/toddler-childhood-alzheimers-symptoms-gets-experimental-treatment-101733208--abc-news-wellness.html
This Chinese Stock Soared 4,500% on Nasdaq and No One Knows Why.
If data is great this could happen to NTRP before forward split.
https://www.bloomberg.com/news/articles/2017-03-30/this-chinese-stock-soared-4-500-on-nasdaq-and-no-one-knows-why
What are the chances of this happening with great data results? "Conditional Approval" "Commercial Marketing Approval"
Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper
Last Friday, Forbes health care editor Matt Herper and I sat down to talk about my proposal, which I detailed in a paper for the Manhattan Institute, to encourage the FDA to approve more drugs after mid-stage phase II testing, using a process called “conditional approval.” (You can read my proposal, in three parts, here.) Matt put forth some very perceptive critiques of the idea, which I respond to in today’s dispatch.
As a refresher, my proposal builds on an existing FDA procedure called accelerated approval in which the FDA approves drugs that show great promise in phase II, with the caveat that the drug sponsor must still perform confirmatory phase III studies. If the phase III studies ultimately show that the drug doesn’t work as advertised, or has previously unknown safety issues, the FDA can revoke its approval. This is exactly what happened when the FDA revoked the approval of Avastin in breast cancer, after phase III tests did not reproduce the early signal of benefit that the drug had shown in phase II studies.
The problem is that the accelerated approval process is only available to drugs for serious, life-threatening diseases like cancer. It’s not available for the common, chronic disorders, like diabetes and heart disease, that affect hundreds of millions of people. As a result, fewer and fewer companies are bothering to develop drugs for these important diseases. So I am advocating a conditional approval process, similar to the existing accelerated approval process (but with some important technical differences), that companies could use in virtually any disease area.
https://www.forbes.com/sites/aroy/2012/05/04/should-the-fda-approve-more-drugs-after-phase-ii-a-response-to-matthew-herper/#43e8dae643e8
Alzheimer's: Every Minute Counts-PBS Rebroadcast 3/4/17
CBS Morning News is promoting it.
Monday should be interesting
http://www.pbs.org/tpt/alzheimers-every-minute-counts/home/
Hey guys I know that am getting ahead of myself but I was looking at PSTI path for Early Marketing Approval which is very interesting. I have a question. AD fall under unmet medical need right? So, beside these path below. If data is good Is there any other path a drug can be approve for marketing while phase 3 is being run ? I mean, if we get data result like the three compassionate patient I know, I know long shot but, it could happen. Can phase 2 result be sufficient for Marketing Approval while conducting phase 3 ?
Priority Review
Breakthrough Therapy
Accelerated Approval?????
Fast Track
Your right!
Trenches, I think Jenni was the fourth patient that was bedfast and was showing remarkable recovering before she got pneumonia and pass away so, technically it would be 4/4.
http://ireport.cnn.com/docs/DOC-1252592
http://seekingalpha.com/article/4046795-neurotrope-bioscience-upcoming-alzheimers-trial-results-may-propel-share-price
By the time Jenni was enrolled in BRNI's compassionate-use trial, she had been bedfast and mute for nearly a year. Spencer remembers the moment when, hours after her first dose of Bryostatin, she reached to him for a high five - her arm fully extended to meet his for the first time in months.
The first night, I had a medicine alarm go off - I gave her medicine about seven times a day - and when it went off, she was upset and started vocalizing, trying to talk," he said. "I was blown away by that, because she hadn't done that for months. She was fussing, and so I said 'Tell me what's wrong, honey. I'll do anything I can to help you.' And she said, 'hot.' Speech had returned after 12 months of nothing, the day after the first dose.
Jenni continued to improve as the trial progressed, according to Spencer. She regained more than 20 words over the next several weeks, he said, and could do many of the speech therapy tasks she had lost months before.
"This stuff works," Spencer said. "She'd lost the ability to drink through a straw prior to the drug, and after she started taking it she regained her ability to drink through a straw and swallow. It was a really amazing thing to witness."
http://www.npr.org/sections/health-shots/2016/06/08/481147958/fda-moves-to-speed-access-to-compassionate-use-drugs?sc=tw
FDA Moves To Speed Access To Compassionate-Use Drugs
The Food and Drug Administration has reduced an obstacle from its compassionate use policy, streamlining paperwork that physicians must submit to obtain experimental drugs for patients with life-threatening illnesses.
Doctors will now file an application for FDA approval that contains just 11 questions, 15 fewer than the old form. They should be able to complete this new version in 45 minutes, the FDA said. The new form is simpler because it was designed for individual patients, replacing an all-purpose format that had been used by doctors acting on behalf of individuals or groups of patients.
There had been concerns that doctors might have been deterred from applying for compassionate access, which is also known as expanded access, says FDA spokeswoman Sandy Walsh.
The policy is intended to help patients with incurable diseases who have tried all standard therapies and hope to extend their lives by taking experimental drugs not yet approved by the FDA, says Dr. Edward Kim, chair of the Department of Solid Tumor Oncology at the Carolinas HealthCare System's Levine Cancer Institute.
The FDA's old form was a "pretty laborious process," Kim said. When doctors are serving patients whose time is running out, every minute saved on paperwork can help, he said.
In streamlining its path to approval, the FDA has bolstered a larger movement to make experimental drugs more accessible. Currently, 20 states have "right to try" laws aimed at improving terminally ill patients' access to experimental treatments, according to the Regulatory Affairs Professionals Society.
Despite benefits for time-pressed physicians, the FDA's slimmed-down application form might not do much to speed those drugs to patients whose time is running out.
Doctors still must first obtain a letter of authorization from that drug's manufacturer. The FDA can't compel drugmakers to grant permission. Manufacturers might reject requests because they're worried about liability if the drug causes harm or they might consider the drug unsuited for a particular patient.
"There has been a tendency to focus on this FDA paperwork as the significant part of gaining access to drugs, but where most requests stop is with the company making the drug," says Mark Fleury, a policy analyst at the American Cancer Society Cancer Action Network.
After doctors get manufacturers' consent, they next submit an application to the FDA. The agency has approved 99 percent of the applications filed for the past six years, FDA figures show. Only 14 out of 1,430 applications were rejected in fiscal 2015.
Expanded access is intended for patients unable to get drugs that are being tested in clinical trials. Sometimes a patient is unsuited for the trial or there might not be a trial to enter at the time the patient needs the drug.
Investigational drugs aren't without risk. The FDA hasn't vouched for the safety of these drugs and they could cause unexpected and potentially deadly side effects, such as liver damage.
They may also be ineffective. Just because a drug is working for one patient in a clinical trial doesn't mean it will work for someone else.
But in situations like these, it's hard not to hope.
I don't post often but, can you imagine the thoughts that will go threw the shareholders minds if, come Tuesday afternoon the stock gets halted for material event. That will definitively be an exciting emotional time event for speculation.
Medication gives opioid addicts fighting chance to quite
http://www.dispatch.com/content/stories/local/2016/04/24/medication-gives-opioid-addicts-fighting-chance-to-quit.html
Speedy drug approvals have become the rule not the exception
http://www.nytimes.com/2015/05/02/upshot/speedy-drug-approvals-have-become-the-rule-not-the-exception.html?_r=0&abt=0002&abg=0
Thank you
If final enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. Can somebody give year for estimation of completed trail and completed Final data read out thanks.
Interesting Article
30 Stars and Doctors Sign the 'Petition for Briggs for Cancer Immunotherapy for All'
http://www.huffingtonpost.com/paul-sanderson/30-stars-and-doctors-sign_b_5652713.html?ncid=txtlnkusaolp00000592
From Sheff
$MRK..Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma
http://t.co/hwQnRENkWu
I like your thoughts well said.
Voskuhl found that, after two years, patients taking Copaxone and the placebo began to show improvement, but those results took longer to appear and were not as strong as those of the group taking Copaxone plus estriol.
Binks, you think that the group that did better then placebo according to digital might have been refering to Copaxone plus estriol. 47% "persisted in favor of the Trimesta" which shows consistency after 24 months of treatment.
"persisted in favor of the Trimesta" Does this mean that 47% was continuous after 24 months of treatment and that plus Copaxone placebo reduction in relapse was 32%. If so, where did we miss the end point.
women receiving Trimesta plus Copaxone demonstrated a statistically significant 47 percent decrease in annualized MS relapse rate in the first 12 months of treatment as compared to women receiving placebo plus Copaxone. In addition, a significant improvement in cognitive function was observed at 12 months as measured by Paced Auditory Serial Addition Test (PASAT) scores. After 24 months of treatment, the reduction in relapse rate persisted in favor of the Trimesta plus Copaxone treatment group compared to the Copaxone plus placebo group (32 percent). Both treatment groups exhibited improvement in measures of cognitive.
Celebrity Advocates for Diabetes
http://www.rxwiki.com/slideshow/celebrity-advocates-diabetes?utm_source=Synacor-Network&utm_medium=Syndication
Interesting article, sorry if this already has been posted. Its all about managing your health and this is what afrezza offers.
A U.K. doctor has stirred up controversy after writing an op-ed in the U.K. paper The Spectator where he argued that he’d “rather have HIV than diabetes."
Dr. Max Pemberton, author of “The Doctor Will See You Now” and who works in mental health, wrote the article to highlight how having diabetes, particularly Type 2 diabetes, can be thought of as “worse” than being HIV-positive, which is now often treated as a chronic, and not necessarily fatal, disease.
“The risk of stroke in newly treated type 2 diabetes is more than double that of the general [U.K.] population,” Pemberton wrote in his article. “To put it starkly, the latest statistics show that because of Haart (Antiretroviral medications), HIV now no longer reduces your life expectancy, while having type 2 diabetes typically reduces it by ten years. But this isn’t an easy thing to say publicly.”
Pemberton highlighted facts such as the life expectancy in the U.K. for those with HIV is only minimally lower.
Porn Star Tests Positive For HIV
However, at least one expert says that Pemberton’s argument does a disservice to both diabetes and HIV, by arguing that one life-threatening disease is “better” than another.
Dr. Kenneth Mayer, professor of medicine at Harvard University and medical research director at Fenway Health Clinic, which provides primary and specialized HIV/AIDS care, noted the two diseases are very different in how they are acquired and treated.
“My whole point [is it] shouldn’t be either or. They’re both important,” said Mayer. “There may be more people at risk for diabetes [globally], but HIV is transmissible,” between people.
Pemberton could not be reached immediately by ABC News for further comment.
One important distinction, experts said, is that Pemberton is speaking as a U.K. citizen. In the United Kingdom, HIV affects far fewer people than in the U.S., with approximately 77,600 people infected in the U.K. versus approximately 1.1 million in the U.S., according to the Centers for Disease Control and Prevention, and the U.K. National AIDS Trust.
Born with HIV, Life at 29
However, not every expert completely disagreed with Pemberton’s article.
Dr. Joel Gallant, chair of the HIV Medical Association and medical director of specialty services at Southwest Care Center in Santa Fe, N.M., said the statement is not preposterous if you look at how effective HIV/AIDS medications are today in comparison to the treatment options for diabetic patients.
“I wouldn’t want anyone to interpret my words as wanting to have HIV. ... We don’t know, for example, that a person with HIV, even very well controlled, is going to have the same exact quality of life as someone without it,” said Gallant. “Nobody should think of it as a non-issue [but] as chronic diseases go the treatment for this is better than most.”
But Mayer said it’s important the articles such as Pemberton's don’t make people complacent about the status of HIV treatment in this country or globally.
“I’m not very happy with the article. I think comparing two serious illnesses is not very useful,” said Mayer, who explained there are still many hurdles towards treating people with HIV in the U.S.
Although Mayer concedes Pemberton's point that medications have made HIV very manageable, he said it has been difficult to effectively diagnose people who have the disease.
According to the CDC, about 25 percent of people with HIV are successfully keeping their virus under control through medication. Worldwide, fewer than 11 million people are being treated while more than 35 million people have the disease, according to UNAIDS.
Rates of HIV infection in the U.S. have remained about the same since around the mid-1990s at about 50,000 new infections every year, according to the CDC. And according to a 2011 CDC report, there are still around 15,000 deaths from HIV/AID in the U.S. every year.
Mayer said approximately 20 percent of people with HIV in the U.S. do not realize they are infected with the disease and it can be years before they show symptoms. Additionally, while medication has been shown to help keep the disease in check, experts are concerned about the effects of long-term use.
“That again is why I’m not so thrilled about the article,” said Mayer. “We don’t know what long-term consequences of HIV combined with aging. HIV might lead to higher risk of cardiovascular [complications.]”
I want to thank everyone that has responded and say that you guys are world class. I been lurking for quit some time and always new that this group had much integrity that other boards can use as an example. Great awesome advise and thank very much once again.
errett, that is the only thing thats keeping me on the fence is the ALH-401 uncertainty. I consider myself a swing trader but, I have two companys that I am holding for long term and would like to add this one as well. If the recoving stroke trail is positive this is a easy 100% gain. The question for me is should I buy now, buy later after negative data at a low price or buy after a huge gain on positive result. Either way I will be buying this stock the question is when. I would like to hear more discussion and opinion on ALH-401. With that being said, what would be the majority on this board approach on investing or trading this particular stock base on this event thank you.
Thank you very much.
You mention that "news outlets picked up on a couple of trial participants and that it was promising". Was there any follow-up on this speculation or rumors from other news outlet that you know of thank you.
Different ways to attack through this platform. I am just starting to do should DD. Any further direction would be appreciated.
The NuroPro Blood Test is Amarantus’ diagnostic platform for the early detection of neurodegenerative diseases. It is being developed as a tool to assist physicians to more accurately diagnose disease and monitor progression. The platform involves monitoring the concentration of 57 protein markers in blood serum identified to be linked to neurodegeneration in order to accurately detect and distinguish between Alzheimer’s disease, ALS (Lou Gehrig’s disease), and Parkinson’s disease. Amarantus’ license is focused on the further development of a subset of 21 of these protein markers specifically targeting early diagnosis and ongoing monitoring of Parkinson’s disease. Given the length of time it takes to accurately diagnose Parkinson’s disease and the relatively high early misdiagnosis rates, the development of a blood-based biomarker test is likely to generate significant interest among neurologists and primary care physicians as it will allow them to intervene at an earlier stage in disease progression.
Hang in there Angry Goat. Silent only means that hope is working behind the scene.
Beta amyloid, he thinks, is one of many things that can stress cellular garbage disposal in the brain. One of these things is tau, another protein used in cells to hold open channels so they can receive nutrients. When tau misbehaves, it clumps together, and the cells can’t get the food they need. What’s more, once the tau’s gone bad in one area of the brain, there’s a runaway chain reaction in the brain. Slowly, more and more of the tau goes bad, until a patient has Alzheimer’s disease.