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Sharkee2, when I was reading your post I jumped on my chair!
100 billion / about 250 million shares = 400 pps, maybe you meant 10 billion market cap, in this case 10 billion / 250 million shares = 40 pps would be a possible listing by 2017.
Anyway, I can't believe it's possible to get 100B + market cap in the next 6 months!
Maybe after dilution of 2.25 billion shares ...
I agree, anyway I meant to say if Accelerated Approval can sweep away like a cyclone all naked shorters ...
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Doc, in your opinion, what could happen to naked shorts if NWBO suddenly release news of Accelerated Approval?
Obviously by June, without Reverse Split and without Dilute …
Thanks!
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... Gottlieb also advocated for incorporating more Patient Reported Outcomes (PROs) as endpoints in clinical trials.
- See more at:
http://raps.org/Regulatory-Focus/News/2017/04/27/27423/Senate-Committee-Advances-Gottlieb-Nomination-as-FDA-Commissioner/#sthash.fmBti1gD.dpuf
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The only way to avoid a Reverse Split and subsequent dilution:
- We must pray the Saint Dr. Scott Gottlieb (new FDA Commissioner) for immediate ACCELERATED APPROVAL of DCVAX-L, without extravagant bureaucracy.
- I pray to Saint Gottlieb every day!
- June, July, are too far away for survival of NWBO, and all "long" shareholders… and many people suffering from cancer, around the world…
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Unfortunately bad advertisement on TheStreet:
Northwest Bio Receives SEC Subpoena and Other Awful Nuggets From New 10-K
By Adam Feuerstein - Apr 18, 2017 8:52 AM EDT
https://www.thestreet.com/story/14089965/1/northwest-bio-receives-sec-subpoena-and-other-awful-nuggets-from-new-10-k.html?puc=yahoo&cm_ven=YAHOO&yptr=yahoo
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1) I am less worried than with other FDA commissioner.
Gottlieb will be under observation by all, he will have to give a good impression of itself ...
Surely it will be a tough choice whether to approve immediately DCVAX-L and marginalize many Big Pharmas, or delaying the approval of DCVAX-L, with the intention of sending bankrupt NWBO.
Soon after, a BP could acquire NWBO in Exchange for a few peanuts and get approval later.
It all depends on the success of data that will be announced by NWBO, to avoid that the FDA would say "no" or "add more further study".
2) Better so if Gottlieb was a follower of AF, he should know NWBO and thus have a clear idea of what to do ...
Surely, Gottlieb is not a clueless and will consider the final data of NWBO and not the chatter of AF !!!
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Gottlieb's recent financial disclosure letter to the Health and Human Services associate general counsel for ethics as evidence. In that letter, Gottlieb disclosed financial relationships with over 25 entities, many of them giants in the biotech and pharmaceutical industries.
https://extapps2.oge.gov/201/Presiden.nsf/BD4592091CA01C31852580F2002C008C/%24FILE/Gottlieb,%20Scott%20finalEA.pdf
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http://edition.cnn.com/2017/04/04/health/fda-gottlieb-background-qualifications/
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Yesterday no confirmation, only a comparison in the Capitol with senators.
We are waiting for, perhaps by Friday ...
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Furthermore he said:
Gottlieb promised to bring best practices to those areas in the FDA that have been lagging.
There’s been an “uneven adoption” of the breakthrough drug program, he added, which now requires broad adoption.
The prospective commissioner also said that while he was not critical of Phase III, there is a possibility with new technology to compress Phase II and Phase III into an adaptive design. ...
https://endpts.com/democrats-ready-a-barrage-of-criticism-for-scott-gottlieb-as-he-heads-for-the-senate-hot-seat-today/
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Do you believe that dates (6/17 - 7/17 topline data) could be anticipated with appointment of Gottlieb to FDA commissioner?
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Despite Democrats’ concerns, Gottlieb is expected to be confirmed easily.
... One issue that worries Gottlieb’s critics is his desire to use more “real-world” results as evidence when weighing whether to approve new drugs and devices. There’s no precise definition of the phrase, but it’s often used to refer to information gleaned outside of rigorous clinical trials, such as information from patients’ electronic records. ...
https://www.statnews.com/2017/04/05/gottlieb-fda-profile/
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Barring a last minute surprise, Gottlieb’s confirmation as the next FDA commissioner is all but guaranteed.
... Gottlieb promised to bring best practices to those areas in the FDA that have been lagging. There’s been an “uneven adoption” of the breakthrough drug program, he added, which now requires broad adoption. The prospective commissioner also said that while he was not critical of Phase III, there is a possibility with new technology to compress Phase II and Phase III into an adaptive design. ...
https://endpts.com/democrats-ready-a-barrage-of-criticism-for-scott-gottlieb-as-he-heads-for-the-senate-hot-seat-today/
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I agree, and I often thought that Big Pharma conspiracy could go beyond the imagination, up to bribe doctors and nurses who perform the Clinical Trial with DCVAX-L.
Replace DCVAX-L with distilled water in such a way that the results are equal to placebo.
Therefore, the survival rate would be higher if it had continued the Clinical Trial honestly ...
Who is a good writer on this board?
I was wondering if it could be a good idea to write a short story about NWBO and get it published by GEN, or whether it is better to suggest to LP to send good news to GEN.
Fom GEN website:
Biotechnology from bench to business
Get your company published in the world’s most powerful biotechnology publication.
Biotechnology from bench to business www.GENengnews.com
Get your company published in the world’s most powerful biotechnology publication...
SUBMISSION GUIDELINES
Print and Online News
Send all press releases to GEN at: editor@GENengnews.com
News is compiled daily for GEN’s online news coverage. The stories are posted each day on our website and distributed in an a daily eNewsletter to subscribers...
http://www.genengnews.com/media/pdf/2017_editorial_guidelines.pdf
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Dedicated to those who love reading: Tag archive for ‘NWBO’
by Apr 26, 2012 to Mar 27, 2017
Welcome to SmithOnStocks
Expert Financial Analysis and Reporting
https://smithonstocks.com/tag/nwbo/
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What you call yourself a "trick pony" with phase 3, maybe it's a "winning horse" disguised as a pony.
Probably LP and LL had already figured out in 2014 to stake everything on the winning horse. Then just achieved success, conclude other pending studies ...
Wait and see!
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On OTC market a 1000% increase is not great, it means an increase of 10 times the current value.
If you want to return on your average price of $ 1.29, you have to hope for an increase about 37 times ($ 0.035 x 36.86 = $ 1.29) which corresponds an increase of 3686% ...
Good luck!
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Thanks, my mistake comes from reading things quickly.
I've lost on Reverse Splits and got out long ago, anyway ILNS has been always on my radar …
The OTC market is strange, good news can also give 1000% increase in overnight!
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I don't know where you looked, I find it always ...
- (It is not even updated Phase 1, which since several months has become Phase 2 ...)
Excuse me, what does it means about following phrases?
... Drugs in development for PSP include: BMS-968168 (Bristol-Myers Squibb) and ABBV-8E12 (AbbVie) both of which are anti-tau antibodies in Phase 1; and several drugs in preclinical stage development.
http://www.intellectns.com/pipeline/target-diseases
- wrong numbers BMS-968168
- correct numbers BMS-986168
I mailed Mr. Maza last week about milestone payment by AbbVie and BMS but he didn't reply me!
I would like to understand whether the agreements with SHIRE, PFIZER, ABBVIE and BMS are still valid and whether ILNS still owns patents or have been sold or abandoned.
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Anti-TauC3 Monoclonal Antibody
Progressive Supranuclear Palsy
http://www.intellectns.com/pipeline/target-diseases
... Drugs in development for PSP include: BMS-968168 (Bristol-Myers Squibb) and ABBV-8E12 (AbbVie) both of which are anti-tau antibodies in Phase 1; and several drugs in preclinical stage development.
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Three studies have been developed in Phase 2, without any Public Release from CEO of ILNS, and without updating some pages of the website...
I did not check PFIZER's study ...
------------------------------------------------------------
1) SHIRE
More Information:
https://clinicaltrials.gov/ct2/show/results/NCT01898884?term=Friedreich%27s+Ataxia+shire&rank=1§=X61&view=results#more
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution may publish results generated from the site individually.
---------------------------------------------------------------
2) Study of BMS-986168 in Patients With Progressive Supranuclear Palsy
https://clinicaltrials.gov/ct2/show/study/NCT03068468?term=BMS-986168&rank=1
Bristol-Myers Squibb: Phase 2
Anticipated Study Start Date: March 30, 2017
---------------------------------------------------------------
3) A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
https://clinicaltrials.gov/ct2/show/NCT02880956?term=ABBV-8E12&rank=1
AbbVie: Phase 2
Study Start Date: October 2016
---------------------------------------------------------------
4) A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
https://clinicaltrials.gov/ct2/show/NCT02985879?term=ABBV-8E12&rank=2
AbbVie: Phase 2
Study Start Date: December 2016
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Slicing NIH Budget 18%, Doubling FDA User Fees ...
http://www.genengnews.com/gen-news-highlights/trump-proposes-slicing-nih-budget-18-doubling-fda-user-fees/81254036
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Is NWBO to release something BIG?
... That said, this company has taken such a beating over the last eighteen months that if it can show that its drug works, there’s only one direction it can travel, and that is upward...
https://www.insiderfinancial.com/northwest-biotherapeutics-inc-otcmktsnwbo-what-the-whitebox-agreement-tells-us/120099/
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I meant to say expect the reform to speed up the approval time!
We are waiting for Senate confirmation... and I also believe NWBO is waiting for...
Dr. Scott Gottlieb is an advocate of faster, flexible approval of drugs e specially where it comes to diseases of material unmet need,” said Bernstein analyst Ronny Gal, adding that Bernstein sees “Gottlieb as generally positive for the drug industry.
http://www.marketwatch.com/story/heres-a-closer-look-at-fda-commissioner-nominee-scott-gottliebs-significant-corporate-ties-2017-03-13
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Unfortunately on link there are old data, the CEO had resigned long ago and AVAX is a ship adrift without a captain, no fuel, no food, ...
I thought CTCA http://www.cancercenter.com/ wanted possession of AVAX and complete the trial of O-vax and M-vax. Or sales of patents to other Pharmaceutical Companies.
Last year, I sent email to many Big Pharma to demonstrate the great potential to acquire AVAX for low price, or to enter into partnership.
My hope is that something is happening behind the scenes ...
Maybe someone is trying to buy shares gradually (average of about 200 thousand per day) to avoid the sudden rise in price ...
I'm waiting for the miracle of President Trump to eliminate the FDA bureaucracy!
AVAX on hands of an astute businessman could reach $5 in one night ...
https://www.nytimes.com/2017/02/05/health/with-fda-vacancy-trump-sees-chance-to-speed-drugs-to-the-market.html?_r=0
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Unfortunately on link there are old data, the CEO had resigned long ago and AVAX is a ship adrift without a captain, no fuel, no food, ...
I thought CTCA www.cancercenter.com/ wanted possession of AVAX and complete the trial of O-vax and M-vax. Or sales of patents to other Pharmaceutical Companies.
Last year, I sent email to many Big Pharma to demonstrate the great potential to acquire AVAX for low price, or to enter into partnership.
My hope is that something is happening behind the scenes ...
Maybe someone is trying to buy shares gradually (average of about 200 thousand per day) to avoid the sudden rise in price ...
I'm waiting for the miracle of President Trump to eliminate the FDA bureaucracy!
AVAX on hands of an astute businessman could reach $5 in one night ...
https://www.nytimes.com/2017/02/05/health/with-fda-vacancy-trump-sees-chance-to-speed-drugs-to-the-market.html?_r=0
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... director of the FDA’s Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA’s regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products as part of the Vice President’s National Cancer Moonshot Initiative. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review. ...
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ucm509057.htm
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Wed Feb 15, 2017
... The fate of deregulating the FDA will be driven by its next commissioner. President Trump said last month he has a "fantastic person" lined up for the role.
Candidates, according to sources close to the administration, include former FDA staffer Scott Gottlieb, and Jim O'Neill, a colleague of Trump supporter Peter Thiel who has advocated for allowing some medicines to reach the market once they are shown to be safe, even if there is scant evidence that they work.
A recent survey of drug company executives conducted by Mizuho Securities found that 72 percent said Gottlieb should be Trump's pick to head the FDA.
"There is no groundswell of movement for change," said attorney Jim Shehan, head of Lowenstein Sandler's FDA regulatory practice.
"The industry likes certainty."
http://www.reuters.com/article/us-usa-trump-healthcare-regulation-analy-idUSKBN15U0GP
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Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo
Posted 24 January 2017
... Focus:
You’ve written in the Wall Street Journal and elsewhere about the need for FDA to be overhauled and for red tape to be removed – can you elaborate on those plans? Are there specific types of biopharma and medical device companies that you think would benefit from such changes? What specifically isn’t working at FDA and for whom is it not working?
Gulfo:
“I was commenting on Trump transition goals, if you will, about cutting red tape. I think the agency has the best intentions but there’s a fear – and even when they get it right they get beat up. Out of that fear, the intent and letter of the original law [establishing FDA] is to promote health by ensuring safety and effectiveness [of medical products], but that has migrated over the years slowly and steadily…like a chronic, insidious disease. It’s been slow but I’ve watched it over my career. When I came into the industry – drugs were labeled for safe use and now there’s this absolute notion of safety, we’ve moved from safety and effectiveness… And now safety has become a discussion of benefit and risk and in big diseases, this has become long-term outcomes and survival. That’s all happened out of fear and is not in the regulations. What I’ve proposed is getting FDA back to safety and effectiveness…and we can do this one of four ways: with biomarkers, clinical science and symptoms (ie. blood pressure, tumor size), with disease modification (bouts of migraines per month) and lastly with long-term outcomes. I don’t think I’m calling for a major overhaul…what I love the most about being called the [former Supreme Court justice Antonin] Scalia of life sciences – I want to get back to original intent of the law. I want to get back to ways to not make FDA be in fear. When I was at the Senate Oversight Committee hearing last year, Sens. [Ron] Johnson [R-WI] and [Daniel] Carper [D-DE] both said the same thing to me and they flattered me saying they read every word of my testimony, and then they told me, ‘We invited FDA here and they wouldn’t come, and you basically said ….all we do is beat up FDA…we do call those gotcha hearings, and that has to stop…stop the fear.’” ...
http://www.raps.org/Regulatory-Focus/News/2017/01/24/26670/Potential-Trump-FDA-Commissioner-Choice-A-QA-With-Dr-Joseph-Gulfo/
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... Finally, he got a tailor-made vaccine combining his white blood cells and proteins from his tumor.
The three-round package cost about $45,000 and wasn’t covered by insurance. Elijah’s parents turned to family, friends and sympathetic strangers for financial help. ...
https://www.washingtonpost.com/national/health-science/a-young-boy-a-devastating-brain-tumor-and-parents-who-will-do-anything/2017/02/06/8fe77d64-d6bf-11e6-9f9f-5cdb4b7f8dd7_story.html?hpid=hp_hp-more-top-stories_no-name%3Ahomepage%2Fstory&utm_term=.ca3863184bfe
,
FDA could become less bureaucratic ...
---------------------------------------------------------------
January 20
... The executive order, signed in the Oval Office as one of the new president’s first actions, directs agencies to grant relief to all constituencies affected by the sprawling 2010 health-care law: consumers, insurers, hospitals, doctors, pharmaceutical companies, states and others. It does not describe specific federal rules to be softened or lifted, but it appears to give room for agencies to eliminate an array of ACA taxes and requirements. ...
https://www.washingtonpost.com/politics/trump-signs-executive-order-that-could-lift-affordable-care-acts-individual-mandate/2017/01/20/8c99e35e-df70-11e6-b2cf-b67fe3285cbc_story.html?hpid=hp_hp-bignews3_firstdaynews-0905pm%3Ahomepage%2Fstory&utm_term=.fbb1506d4201
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This is stupid joke, I am not a basher but unfortunately it is same news of the past year 2015.
---------------------------------------------------------------
Date: 3/8/2015
Roche BOD To Vote Yes On Acquisition Of $NWBO As Bidding War Looms..... sierraworldequityreview.blo...
http://stocktwits.com/ssteve_s/message/33691844
-----------------------------------------------
Date: 3/8/2015
Roche BOD To Vote Yes On Acquisition Of Northwest Biotherapeutics (NWBO) As Bidding War Looms Ventures Sierra Equity
Latest Projections: Roche BOD To Vote Yes On Acquisition Of Northwest Biotherapeutics (NWBO) As Bidding War Looms Ventures Sierra Equity. Shares of NWBO finished higher up over 2% at the end of Friday's session. More to follow.....check back as Sierra pursues her leads, look for the official news, when it breaks remember Sierra called this first!
http://boards.fool.com/nwbo-buyout-31661633.aspx?sort=postdate
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Senate Clears Bill to Ease FDA Drug and Device Approvals.
Measure includes money for NIH, cancer moonshot, precision medicine initiative.
Dec. 7, 2016 2:33 p.m. ET
WASHINGTON—Passage of legislation aimed at speeding up Food and Drug Administration approvals, combined with an incoming president who has pledged to “cut red tape” at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation...........................................
http://www.wsj.com/articles/senate-clears-bill-to-ease-fda-drug-and-device-approvals-1481139236?mod=e2tw
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You are right ... we need of miracle to recover our investment!
I believe that CTCA www.cancercenter.com/ has taken possession of all the goods and the AVAX patents.
Perhaps CTCA might be interested to go on Nasdaq, using shares of AVAX ...
---------------------------------------------
What do you think about: no progression study of O-vax and restarted study about M-vax?
Estimated Enrollment: 387
Study Start Date: July 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
https://clinicaltrials.gov/ct2/show/NCT00477906?term=avax&rank=1
Unfortunately: This study is not yet open for participant recruitment
I sent an email to Dr. Henry but without reply...
CONTACTS:
Contact: Henry E Schea 215 241-9760 ext 1302
henry@avax-tech.com
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You are right ... we need of miracle to recover our investment!
I believe that CTCA www.cancercenter.com/ has taken possession of all the goods and the AVAX patents.
Perhaps CTCA might be interested to go on Nasdaq, using shares of AVAX ...
---------------------------------------------
What do you think about: no progression study of O-vax and restarted study about M-vax?
Estimated Enrollment: 387
Study Start Date: July 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
https://clinicaltrials.gov/ct2/show/NCT00477906?term=avax&rank=1
Unfortunately: This study is not yet open for participant recruitment
I sent an email to Dr. Henry but without reply...
CONTACTS:
Contact: Henry E Schea 215 241-9760 ext 1302 henry@avax-tech.com
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Perhaps they are waiting for results of Safety and Efficacy Study of DCVax-Direct in Solid Tumors.
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
https://clinicaltrials.gov/ct2/show/study/NCT01882946?term=dcvax&rank=3
https://clinicaltrials.gov/ct2/show/results/NCT01882946?term=dcvax&rank=3
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Congress set to vote on bill that promises to speed up drug approval:
https://www.washingtonpost.com/news/wonk/wp/2016/11/29/congress-set-to-vote-on-bill-that-promises-to-speed-up-drug-approval/
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You are correct!
CEO is awaiting an imminent Accelerated Approval, anytime by FDA!
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Who bought 136,834 shares, Friday at 16:00 o'clock in closing market?
And, who sold shares the last minute …?
Something is moving underground!
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