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Can you guys say this looks familiar once you get into Germany it could happen to us hit the link and see what happens after you get exclusive rights in Germany Germany has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The product’s safety, efficacy and equivalence have been proven in multiple clinical trials1,2.
"This approval further de-risks our high value respiratory generic portfolio in Europe and the Rest of the World and, provides a significant cash milestone to Vectura." said Chris Blackwell, CEO of Vectura. "Once launched, the royalty stream from AirFluSal® Forspiro® will contribute to Vectura’s differentiated top line growth".
The receipt of the marketing authorisations in Germany and Denmark follows the successful completion of EU decentralised procedures which also include Belgium, Bulgaria, Hungary, Luxembourg, Romania, Sweden and Norway. We will communicate as and when further market approvals are received.
Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz’ global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.
[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric asthma. Submitted ERS – Reference September 2013 http://www.vectura.com/media/press-releases/2014/13-jan-2014.aspx
Thanks for the update lots of excitement having that kind of exposure man do they feel very confident!
Looks like day just add another booth I thought it was 4 ,http://events.jspargo.com/ASCO14/Public/Exhibitors.aspx?Index=N
March 13,2014 By Joseph Hill - Oncology stocks that could offer SUPERNORMAL returns. The second treatment, the medium risk/medium reward treatments, is Northwest Biotherapeutics' (NWBO) DCVax-L. DCVax-L is an immunotherapy treatment targeted at glioblastoma multiforme, one of the deadliest forms of brain cancer. The science behind this treatment roots itself in a patient's immune system. To simplify, there is a special type of immune system cell called a dendritic cell, which help the immune system identify, among others, cancer cells. They break the cancer cells down into antigens, which signal the immune system and elicit an immune response. The immune system attacks every cell that displays the antigens, removing the cancerous cells from the body. Northwest Biotherapeutics manufactures the vaccine from a small piece of tumor (removed via surgery), and the treatment is administered intravenously.
In a small phase I/II trial DCVax-L demonstrated significant efficacy, with 20 patients more than doubling the current standard of care overall survival rate of 14.6 months to 36 months. A much larger phase III trial is currently underway and, if Northwest Biotherapeutics can replicate the early trial results, DCVax-L could expose the company to a multi-billion dollar market. Northwest Biotherapeutics expects to publish the results for the trial before the end of 2015.
To summarize this addition to the portfolio, Northwest Biotherapeutics is a development stage company with no current approved treatments. The company's dependency on the success of its pipeline makes it a risky investment. However, its lead treatment has demonstrated significant efficacy in human trials and final phase trials are currently underway. The company is currently valued $273M, which offers plenty of upside potential in the event of FDA approval for DCVax-L. http://www.investing.com/analysis/oncology-stocks-that-could-offer-supernormal-returns-205913
Zaklina Buljovcic is a biologist by training and holds a PhD in Natural Sciences.
She started her professional career in F&E at a small Biotech Company in Heidelberg, Germany in 2000 and joined PharmaLex in 2004. At PharmaLex she held various positions and established different kind of product groups focusing e.g. on tissue preperations, herbal or veterinary products. Since 2008 she is working at PharmaLex as project manager on various ATMP products supporting mainly SME Biotech Companies. This is including strategic regulatory support, preperation of national and EU Scientific Advices, preperation of IMPDs, as well as dossieres for hospital exemption in Germany and EU Centralized Procedures. She is also one of the leading regulatory experts in Germany for ATMPs, giving regularly lectures on various ATMP-topics and engaging in joint industry / health authority working groups. http://www.eucraf.eu/speakers-a-to-z-listing
NWBO An important thing to remember is, this is no longer just a money losing biotech gamble, NWBO now has a significant revenue source.
Based upon volume and all technical indicators, we remain in an ongoing PANIC BUY wave that MUST result in GAP UP moves for weeks to come.
I believe that's we're we are heading with nwbo this is the most exciting time after years of years of hard work! right on nwbo way to go!
Thanks to everyone on board I want to say I was having quite a bit of a heart attack going through this but now I feel awesome congrats to all the longs this is going to be one big excitement for both parties people that are in need this product people that are holding NWBO!
Recently taken photos and some good reading! Northwest Biotherapeutics CEO Linda Powers sits in her company offices in Bethesda, Maryland, February 22, 2014. Lots of cool photos check it out... http://ph.news.yahoo.com/tiny-northwest-biotherapeutics-aims-dominate-brain-cancer-150858246--finance.html
A manufacturing associate holds a vial with a DCVax-L label in a Northwest Biotherapeutics laboratory in Memphis, Tennessee, February 21, 2014.
http://www.firstpost.com/topic/disease/cancer-a-manufacturing-associate-holds-a-vial-with-a-dcva-image-0coNb2B0Cn3J0-74009-1.html
March 06, 2014 Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603460?displayxml=true
Wow a video you all must see if you haven't on the link to go to four minutes and 30 seconds amazing check it out
Can you give us more color on this!
It's sure is thanks a lot!
I thought this makes a lot of sense read it! burnaka • 1 hour 28 minutes ago
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This is the rebuttal I posted to the AF article, stating facts to bash his article, and an opinion or two
nor has the company explained how or why FDA will be copacetic with a primary endpoint of progression-free survival. "
I find it hard to believe the FDA would give the GO AHEAD for a study but allow the study with an invalid end point. Guidelines from FDA 2007 regarding trials :
Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics"
Quote: "TTP and PFS have served as primary endpoints for drug approval. TTP is defined as the time from randomization until objective tumor progression; TTP does not include deaths. PFS is defined as the time from randomization until objective tumor progression or death. The precise definition of tumor progression is important and should be carefully detailed in the protocol. "
Apparently this quote from the FDA from the trial end points section was missed by the author. PFS is INDEED a valid endpoint.
As far as missing data, or lost data? Really ? That data is considered sacred, it is not lost or missing. Making that type of ASSUMPTION is beyond funny.
The safety data is ALWAYS looked at first Adam, ALWAYS, the data interpretation beyond that can take up to six months before it is DEEMED late, but you do not keep enrolling patients if there is a safety issue.
As far as NWBO responding to investor inquiries it might be that the INVESTOR RELATIONS number was posted on the yahoo message board yesterday, and they had countless calls. They opted to give the partial info that they had in response to this rash of calls, The DATA may take 6-8 more weeks and still be considered timely. DMC's can take up to 6 months before it is considered late. Less
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burnaka • 43 minutes ago Flag
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In a second post to AF I wrote:
To get an SPA in a phase 3 study it has to be before the start of the study, and before one patient is enrolled. NWBO phase 3 was not entitled to be granted SPA because it was a continuation of an on going study. The author should be aware of these basic FDA standards if he writing on this space. He tries using NO SPA, and PFS to hammer NWBO when in fact PFS is INDEED an accepted end point, and NWBO was never entitled to an SPA. Info he either did not know or chose to omit, the former explains why I find his articles manipulative and lacking validity. Less
Thank you that's all I needed to know! Someone else wrote on Yahoo I like the post it here that doesn't make sense..... egkainia • 3 hours ago Flag
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Read between the lines.
What a Greek gift non investors got today... Listen, in a trial of this size and orientation, to say the trial should not be haulted for safety, and that they are still working out the details as to whether or not it should be haulted for efficacy, is the SAME THING as saying there is compelling data to suggest a hault for efficacy should take place. Of course, they can't say that in a PR, but they DID WITHOUT SAYING IT. Again, recall IMUC, in a very similar trial recently. Their data was not compelling, but safe. They got a quick "continue" turn around. Their treatment has subsequently been analyzed in comparison to DCVax L and found much inferior (overly selective). There is only one reason this is taking this long: they are working arduously to determine whether or not the data, which is COMPELLING, is also in the best interest of the company and the patients to call an early hault at this time. In order to determine this, they can leave no stone unturned. Everything has to be reviewed, rereviewed, confirmed, re confirmed, etc. Their finger is on the trigger, and it's the one that if pulled, sends the pps many multiples higher. Less
I think a lot of people got bothered with this statement overall.........What's likely going on here? At best, Northwest Bio has so botched the DCVax study given all the delays and changes made over the years that patients have been lost and their data (scans, etc.) are unreliable. Worst case, DCVax is just a placebo and today's press release is another stalling tactic.
By the way, Northwest Bio still hasn't told investors if the DCVax study is fully enrolled, nor has the company explained how or why FDA will be copacetic with a primary endpoint of progression-free survival.
Why is it so hard to explain this nobody wants to explain this!The only issue I have is this statement kind of bothered me i'd like to get your info on this or anyone else thank you! What's likely going on here? At best, Northwest Bio has so botched the DCVax study given all the delays and changes made over the years that patients have been lost and their data (scans, etc.) are unreliable. Worst case, DCVax is just a placebo and today's press release is another stalling tactic.
By the way, Northwest Bio still hasn't told investors if the DCVax study is fully enrolled, nor has the company explained how or why FDA will be copacetic with a primary endpoint of progression-free survival.
What do you think flipper44 you're good at this explaining it to us! The math says otherwise.
In January, NewLink told investors that the median overall survival for all patients in the study -- both arms -- was 25 months. It's now March, so let's assume the blended median overall survival is 27 months.
NewLink says the phase III study was designed with the assumption that pancreatic cancer patients enrolled into the control arm of the study would have a median overall survival of 17 months.
If that's true, then it suggests median overall survival for HAP-treated patients should be around 37 months, or more than double the control arm and enough to stop the study early for positive efficacy.
Well, that didn't happen, so NewLink's assumption about the median overall survival of pancreatic cancer patients must be wrong.
Using more conservative assumptions doesn't help NewLink either. Let's say pancreatic cancer patients in the control arm should live about 20 months. Using the same blended median 27-month overall survival, this would imply HAP median overall survival of 34 months, or a 70% improvement.
Again, the study should be stopped early for positive efficacy. It wasn't.
None of these back-of-envelope analyses guarantees a HAP study failure, but they do take a serious whack at the optimism of NewLink bulls because the underlying assumptions used to design the study are incorrect. The pancreatic cancer patients in the study are living longer than the company expected, which bodes poorly for the ultimate outcome.
Moving on to NorthWest Biotherapeutics and the phase III study of its brain cancer vaccine DCVax. I read today's press release and thought it must be a joke. Here's what the company said:
Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, announced today, in response to shareholder inquiries, that the Data Safety Monitoring Board (DSMB) has made an unblinded review of the safety data for the Company's ongoing international Phase III GBM Trial, and has recommended that the trial continue as planned. The DSMB's review of the efficacy data is still pending. [Emphasis mine.]
Wow, there's a lot of bamboozling in that statement. Let's work through it all.
"In response to shareholder inquiries." No! Northwest Bio issued a press release on Dec. 10 informing investors that the progression-event trigger had been reached for the first interim analysis.
The analysis was supposed to take 6-8 weeks, which stretched to 8-10 weeks, and then almost 13 weeks.
"Review of the safety data." What? The interim analysis was based on efficacy data, not safety. In this case, independent monitors are looking at patient scans to determine when their brain tumors progress.
"The DSMB's review of the efficacy data is still pending." Oh my. How do independent monitors analyze patient scans for safety but not efficacy? Impossible. Also, how can Northwest Bio claim the trigger event for the first interim analysis was reached last December based on the required number of progression events, but tell us today that the review of those scans is still pending?
Does not compute.
What's likely going on here? At best, Northwest Bio has so botched the DCVax study given all the delays and changes made over the years that patients have been lost and their data (scans, etc.) are unreliable. Worst case, DCVax is just a placebo and today's press release is another stalling tactic.
By the way, Northwest Bio still hasn't told investors if the DCVax study is fully enrolled, nor has the company explained how or why FDA will be copacetic with a primary endpoint of progression-free survival.
This article just came out! http://gdpinsider.com/brain-cancer-drug-key-for-northwest-biotherapeutics-inc-nasdaqnwbo-7339.html#respond Most analysts including those from Oppenheimer & Co have been of the opinion that the phase 3 trials which are currently being pursued by Northwest Biotherapeutics, Inc (NASDAQ:NWBO) on the target drug DCVax-L are a make or break situation for the firm. Analyst Boris Peaker of Oppenheimer has been quoted to have said that, “If the drug holds up in Phase III, it will be a very big win for the company because there aren’t many good options now for patients, and DCVax is certainly better tolerated than any chemotherapy. And if it works in brain cancer, it should work in other solid tumors.”
You forgot one more positive thing nwbo has moved up quite a bit while were waiting even though the short trying to take it down from the high and it doesn't look like they're accomplishing that much with all the newsletters and storm of short Brashers 24 seven posting for couple of days we really haven't moved that much south from the high that tells me nwbo is holding up pretty strong!
Looks like we have an upgrade http://navelliergrowth.investorplace.com/portfolio-grader/stock-report.html?t=NWBO
Just out FEBRUARY 28, 2014 3:49
http://sundiatapost.com/tiny-northwest-biotherapeutics-plans-to-dominate-brain-cancer/
Sorry just got carried away very excited.
Northwest Bio shoots for dendritic success where others have failed
Read more: Northwest Bio shoots for dendritic success where others have failed - FierceBiotech http://www.fiercebiotech.com/story/northwest-bio-shoots-dendritic-success-where-others-have-failed/2014-02-26#ixzz2uWs3qlfn
Subscribe at FierceBiotech http://www.fiercebiotech.com/story/northwest-bio-shoots-dendritic-success-where-others-have-failed/2014-02-26
When purified and injected back into the patient, DCVax-L is meant to prompt t-cells and b-cells to leave the lymph nodes and fan out through the body, seeking and attacking cells having the target antigens. For a graphic, see: link. http://pdf.reuters.com/pdfnews/pdfnews.asp?i=43059c3bf0e37541&u=2014_02_18_11_51_1e754191efe3487890a37f34ab70deb2_PRIMARY.jpg
Technician pulls additional sterilized covers on his arms in a Northwest Biotherapeutics laboratory in Memphis
http://www.universityherald.com/articles/7794/20140226/northwest-biotherapeutics-aims-to-develop-treatment-for-brain-cancer.htm.
I was watching level 2 that actually went above the ask.
Another good video on NWBO - Les Goldman interview.
News 2-21-2014 Humidification of the mouth, throat during RT for head and neck ...
www.checkorphan.org › News › Research
1 day ago - NW Bio Announces That Another Brain Cancer Patient From Phase I/II ... The study was conducted by the Trans Tasman Radiation Oncology Group and ... at three months after radiotherapy in the group using humidifiers. http://www.checkorphan.org/grid/news/research/humidification-of-the-mouth-throat-during-rt-for-head-and-neck-cancer-reduces-mucositis-hospital-stay
In September, Northwest Biotherapeutics activated the second site for a DCVax-Direct Phase I/II trial. The M.D. Anderson Cancer Centers in Houston and Orlando are performing the trial for solid, inoperable tumors, including ovarian, lung, colon, pancreatic, liver melanoma, head and neck, and other cancers. Results are expected by year’s end. DCVax activates dendritic cells, which are injected directly into the tumors to shrink their sizes. http://www.genengnews.com/insight-and-intelligence/ovarian-cancer-treatment-options-multiply/77899912 This was out last year but interesting to read!
Iranian surgeon: brain cancer vaccine is a promising therapy ...
article.wn.com/.../Iranian_surgeon_brain_cancer_vaccine_is_a_promising_...
Jan 4, 2014 - Bob Gibbs was treated with Northwest Biotherapeutics DCVax therapy. ... CBS News Path features a brain cancer vaccine study led by UCLA .... Bob Gibbs was featured along with Dr. Linda Liau on NBC Extra's Lifechangers Segment discussing DC Vax, a treatment for ...... Howard Timmins, Cape Town. http://article.wn.com/view/2014/01/04/Iranian_surgeon_brain_cancer_vaccine_is_a_promising_therapy/