what an incredible bio
if you are unfamiliar with her background you really need to google and read
she has done more than any 10 people i could name
she and her companies own the balance of Northwest common stock -- and they got there through actual funding of the company, not through awards or freebie options
it's the end result that matters -- except for elite, in which case even the end will not motivate investors who are placing almost ALL their emphasis on the abuse resistant studies
and that is unfortunate for them because with elite's pharmacological approach it is actually the pedantic biological equivalency studies that are more important, not the abuse resistant studies
see, for elite's two bead capsule, the resistance to snorting and injecting has long been a moot question. the real concern has been whether the capsule could truly deliver breakthough pain relief OR if the naltrexone would leak out and reduce the effectiveness of the oxy -- and their first drug came out of the BE studies with patients saying they preferred elite's capsule for pain relief over the original!
so, the market is not reacting to the start of another BE study and will not react, much, to even the completion but it will most definitely react when the abuse resistant studies results are reported -- all of which is actually backwards for elite's two bead drug formulas but why bother trying to educate the masses now when it will all work out in the end anyhow...
the question came via a comment to yesterday's Seeking Alpha analysis of imuc's announcement of results. the question had to do with why the FDA doesn't just approve drugs like imuc's that have established a good safety record and have solid evidence they offer some help for terminally ill patients instead of waiting for lengthy phase III trials to take place. Larry's response...
"The German regulators made such a decision with DCVax-L when they approved it under the hospital exemption early access program. DCVax-L can be prescribed by German oncologists and reimbursed for all glioma patients in Germany. NWBO can't market the product directly but unquestionably physicians and patients are aware of its availability and it will be prescribed.
The Germans are leaders with this initiative. However, DCVax-L also can be prescribed for GBM in the UK but not reimbursed. US investors have confused these approvals with an older compassionate use programs which are quite different and limit product use. Hence, the value of these approvals is not reflected in the stock. The US has accelerated approval but this still requires more extensive clinical trials and isn't comparable.
What you are suggesting is possible in Europe but. The "but" is that NWBO worked on gaining these approvals for two years and IMUC has not yet started the process. As importantly, NWBO established and gained regulatory approval of commercial scale manufacturing in Germany. Again, IMUC has not begun what is probably a two year process. This was brilliant execution on the part of NWBO.
I see no possibility of this hosptial exemption early access approval for safe and probably effective products for life saving diseases being allowed in the US in the next year or two. If such a program were somehow approved, it would take a year or two to get a drug through the program."
why do you keep posting that the results are overdue when they are not
phase III continues as planned
the ceo said results from the first 66 events could come out in about two months, and they were delayed a bit by the independent committe (over which Northwest has no control because, after all, the committee is independent)
the results from the first 66 events said the trials should continue because there were no safety issues
what more did you expect, or do you want now -- 66 events (recurrence or death) is not a lot to be basing a final decision on with about half in the control group, so a continue should have been expected even if the results to that point were very, very positive
as for talking about preliminary of unnamed individual patients in the D trials, it is unblinded and everybody knew that with so many different cancers being addressed that results would be coming out at different times for different patients and, far from being exploitive, it is very encouraging for those with cancer to hear positive news on a treatment from anywhere anytime -- keeps their spirits up, especially when Northwest could get surprisingly quick approval and be treating patients that otherwise would be giving up hope
try looking at this whole process with a bit more compassion
"Ms. Linda F. Powers, J.D., has been Chief Executive Officer of Northwest Biotherapeutics, Inc. since June 08, 2011 and serves as its President, Principal Accounting Officer and Chief Financial Officer. Ms. Powers serves as Managing Director of Toucan Capital Corp. and Toucan Capital Fund II, L.P. She is a Co-Founder of Toucan Capital Corp. and Toucan Capital Fund II, L.P. She has more than 25 years of experience in the fields of venture capital, public-private partnerships, corporate finance and restructurings, mergers and acquisitions, joint ventures, IP licensing and highly leveraged, structured, and specialty finance transactions and more than six years of experience in seed and early stage venture capital investing. Prior to Toucan Capital, she served as Senior Vice President of Global Finance at Enron Corp. Prior to joining Enron, she served as a Deputy Assistant Secretary of Commerce in the Bush Administration from 1989 to 1993. In that capacity, she was responsible for a number of small business programs, mainly concerned with access to capital. She also assisted financial services, information services, and related businesses in entering foreign markets and was responsible for government to government negotiations to remove foreign market entry restrictions for U.S. firms. In addition, Ms. Powers served as a co-lead negotiator for United States on the North American Free Trade Agreement and financial sector agreement, which opened banking, securities, insurance, pension fund, and related opportunities in Canada and Mexico. During 1980’s, she practiced law, specializing in corporate mergers, acquisitions, and financings and certain kinds of intellectual property transactions. While working for the headquarters of the European Union in Brussels, she was responsible for drafting the initial intellectual property rules, which now govern know how licensing in the European Union. Ms. Powers has been the Chairperson and Director of Northwest B
these results are absolutely astounding
others have mentioned this but it does not seem to be getting much attention, and it is an enormous endorsement or at least recognition of the 'L' vaccine's importance
go to evaluatepharma world review 2014 and enjoy a wealth of info on the health of pharma while noting that the 'L' vaccine is in deed ranked high amongst the big time R&D projects of the majors
have to suspect that Northwest's Direct vaccine will be even higher on their list for 2015
good press from The Street late last week
all good drivers for this week because all the exposure brings in new investors
doesn't hurt that all the news continues to be better than could be expected -- nobody can claim they really thought three patients would have NO cancer cells left -- which means it has NOT been priced into the stock and that kind of news quickly creates a launch pad for companies in this space...
communication -- this has been designed as a safety trial, and Northwest needs to keep highlighting that over and over if efficacy observations are going to be discussed
communication -- Northwest does NOT have any efficacy endpoint at this time for the Direct trials -- they still have to be worked out with the FDA and they need to keep stating that when talking about efficacy
communication -- somehow the notion started circulating that the first patient experienced 50% tumor shrinkage (Smith later upped it to 65%) when all Northwest had used was adjectives described the extent of necrosis. then we find out that shrinkage has been up to 28% (whether first patient or not, we do not know) so there is a big let down. but Smith should never have gotten folks thinking about 50% let alone 65%. especially since researchers don't seem sure that shrinkage is a valid criteria -- or even a desired outcome. it could be that stopping the spread will equal survival, and that leaving the tumor in place is best
communication -- count me among those who think the PR on German approval was lacking in that Northwest should have included information as to:
-- whether they were ready with current facilities to treat patients and how many
-- when the expanded facilities would be ready and how many additional patients could be treated
ipci's own presentation slides estimate only a few million total for all of their pipeline except rexista
and rexista is so speculative and so many years away from any possible approval that it is a non factor
"The Company was very much encouraged that no live tumor cells were detected and immune cells were found in biopsies of three advanced and aggressive cancers; one metastatic pancreatic, one metastatic colon cancer and one metastatic sarcoma. It is important to understand that this trial is being conducted in patients with very aggressive or bad tumors for which there are no approved therapies. These three cancers are the “baddest” of the bad. The severity of the disease in these patients makes the results even more noteworthy."
with current stock price, that is all that matters
fwel, a buck thirty-seven would mean a $770 million market cap, and that is a bit below where elite should be right now without any of your 'needs' list
all that matters is that Hakim is on schedule with the abuse resistant line, and it is the growing potential for approval that justifies a higher price
stop talking about little isradipine and the rest of the known generic druglettes (rather doubt the unknowns are worth much more) and 10k/10q numbers as all of that together without the abuse resistant line would just crash the market cap
elite is NOT a generic drug company trying to become an abuse resistant leader, it IS a company swinging for the fences and ONLY interested in the home run. it continues with the generics because it is there and can bring in some cash flow but understand that Hakim farmed most of it out to epic because he doesn't need the distraction and he will sell if off very quickly when the abuse resistant line hits the market and, if the abuse resistant studies fail, Hakim will be out of here in a flash
hyping those generics in the same breath as the abuse resistant line does not help the stock and shows your lack of perspective, history, and potential
"Under the Purchase Agreement, on any business day selected by us, we may direct Lincoln Park to purchase up to 500,000 shares of our common stock on any such business day. On any day that the closing sale price of our common stock is not below $.65 the purchase amount may be increased, at our sole discretion, to up to 600,000 shares per purchase, on any day that the closing sale price of our common stock is not below $.80 the purchase amount may be increased, at our sole discretion, to up to 700,000 shares per purchase, on any day that the closing sale price of our common stock is not below $.95 the purchase amount may be increased, at our sole discretion, to up to 800,000 shares per purchase."
she establishes right out of the box that the vaccine is "conroversial" and then proceeds to give f'nstein credibility by singling him out as one of the "critics" though he seems to be the only one
she glossed over German approval as if the action was a routine matter for the PEI
she said nothing about the UK or the overall scope of the trial, nor did she mention the FDA recently approving the vaccine for those patients who did not make it into the trials
AND she referred to the efficacy data as "still pending" when it never was even due at the first interim
bottomline -- emily must be sleeping with adam
and their drugs are ordinary and easily be added to existing channels and much more efficiently handled by an established distributor
oh, they have dreams, they have visions, they have aspirations
well, that kind of stuff is common when little companies first get a whiff of revenues but, unfortunately, there is no record of these people building much of anything beyond the whiff and tease phase
the market is not it great need of yet more of the generic druglettes ipci is focused on, and rexista (which has already been shown to have less than optimal abuse resistance) is a project requiring quite a few years and many more millions than they are even proposing to raise with this latest shelf registration
those who have been here and realize that the bioequivalence study was the higher hurdle know that the stock should already have a market cap of $800 million to $1.3 billion. the abuse resistant studies are just a formality for those of us who appreciate that elite's two bead formula has already passed that test as it existed when elite completed the phase I/II trial. they are only updating it now to meet the new policy that FDA issued last year requiring independent third party testing (of which there are only two such parties in all of North America) but it is truly a formality at this point -- except to the low information investor who does understand that elite has already cleared the abuse resistance bar once before
really, the big concern for those who have been here a while was that the naltrexone would leak in real world use which would render the oxy and the pill useless to pain patients. this is because the patents have not been based on real world testing
but the FACT that the naltrex remained isolated during the bioequivalency study and the FACT that patients actually got better pain relief from elite's two bead than they did with original oxy would have caused elite to achieve the market cap just stated if enough investors understood that it was bioequivalency and not abuse studies that were key for elite's UNIQUE two bead approach
its all clear sailing for longs now, and there will be a very pleasant surprise when the results of the abuse resistant studies are released and all the low information investors -- who minimized the significance of the bioequivalency results while falsely thinking the abuse studies were in doubt -- start piling in
"NWBO's Phase III clinical trial was also "adopted" as a national priority trial in the UK, under the "adoption" program managed by the National Institute for Health Research (NIHR), which is part of the UK's National Health System. This "adoption" of the Company's Phase III trial constitutes a significant validation, and also carries with it resources and operational support for the trial sites.
The NIHR maintains a portfolio of clinical trials that have been "adopted" as high priorities for the UK. In order to be selected for the NIHR Portfolio, a proposed clinical trial must go through multiple layers of review and evaluation. The evaluation includes the potential significance of the new medical technology being tested, the quality of the trial design, the feasibility of the trial, and numerous other factors.
Trials that are selected ("adopted") for inclusion in the NIHR Portfolio are monitored closely by the NIHR and the trial sites receive several types of financial and operational support. For example, the NIHR provides resources and funding for additional staff (e.g., nurses) at the trial sites to help accelerate the trial. The NIHR also oversees the performance of the sites, and imposes penalties on the sites for shortfalls such as lags in enrollment."
particularly troublesome is that this happy chatter has been a constant fixture on this board to the point that much of it is now treated as just another boy yelling wolf
i mean, we are on our second CEO now talking about a partner being just around the corner but our resident pompom pumpers treat it like it is a novel (no pun) idea
we continue to be funded from private sources, with no real institutional interest in a stock that the board seems to think is a 10-bagger minimum
so many continue to claim with certainty that the price will launch when a BE study is done or a drug moves on to the next stage or whatever, but the stock has not moved on that type news before
and, though hardly anything has ever happened on schedule (isradipine is latest example), most of the posters here seem to have entered time and date for every study to finish, results to release, and drugs to be filed -- and completely rejecting the possibility of the FDA doing anything but stopping traffic and waving elite through
then there is the assumption that elite is suddenly fully financed, cash rich, and maybe even should be buying back stock! folks, this continues to be a bare bones operation with management taking shares in lieu of salary and debts being paid with shares whenever possible. the money from LPC comes in gradually, which can delay trials if FDA requires them, and could easily fall short of funding whatever FDA may require
and finally we need to consider who is doing all this repetitive cheerleading. it's pumpers like gordonhooch who long ago said the diet pill was going to bring in $40 million in revenues per year(!) and recently said 4th quarter revenues would be $3.8 million instead of the $1 million reported
board needs to settle down, board needs to take a breath, board needs some balance