If it is up after ONT-10, or the company as a whole in the next few months, then that would be really naive from the side of Merck KGaA!
Thank you my friend. This ongoing torturous process will increasingly shake out more retail investors and leave door open to more accumulation from institutions. All are benign process and much needed for next leg up.
Just want to add: in addition to those 55 patients, there are currently about 85 patients in the ongoing DCVax-L Ph2 trials at UCLA. The data of the trial has a readout day of September 2014.
Also in the know is those up to 99 patients who are enrolled or going to enrolled in the ongoing "Expanded access arm" who are not qualified for included into the Ph3 L trial.
There are also compassionate use data generated from Germany, Israel, etc.
WHAT ARE THE COMPANY GOING TO USE ALL THESE DATA! HOW CAN FDA NOT BE IMPRESSED IF DATA ARE STRONG AND SUPPORTIVE FOR AN AA APPROVAL!
1) After Germany's approval of L (under HE framework), I assigned 60% chance for L's success. After yesterday's two prs, particularly the one concerning the state of those 55 patients, the chance goes up to 80%;
2) D's success is obvious if you believe the data published by the company. It's not if now but when can D be commercialized IMHO!
3) From the recent trading patterns and detailed analyses of each trade, it is obvious that institutions have started serious accumulation, which is also supported by some which have reported about their holding. Even today's trading is a strong sign of serious accumulation;
4) AF's influence on share price will continue with most small biotech companies, but as evidenced with today's episode, it seems that his influence (derived from cooperation from HF short selling) has dwindled to almost non factor. Note that most biotech companies saw share prices down today;
5) Don't underestimate the wisdom of our CEO, Linda Powers. As we all speculated on various possibilities about the first interim, she was working hard behind the scene, and it took nine long months to get L-trial modified & approved;
6) I genuinely believe when she started working on trial modification, she knew nothing about the efficacy of the vaccine (blinded), and she still does. The purpose of trial modifications was legitimate and strategic for not only addressing new factor but also increasing confidence level for trial success.
7) Superficially, it seems that the final read of data of L trial has been postponed to late 15 or early 16 for 248 events to happen. But, if those 55 patients are a hint, which I believe, the treatment arm would be strongly suggested to have at least the same efficacy so that the trial will end at its first interim late this year or early next year.
8) I strongly believe LP is working on various possibilities for L & D, such as AA for both. I would not be surprised to hear a big good news coming in the near future!
that 88 event is now the past, obsolete!
Trial enhancement: a) there will be a small overall size increase but a substantial increase of final event count from 110 to 248 to have taken into account of newly found factors, and to enhanced statistical power in detecting a lowered benefit PFS from the original 6 months to today's 4 months.
Coupled with the news about 55 patient treated in the compassionate arm which is not blinded: the usual overall survival for this group of patients is normally only 7 ~ 10 months, but the average survival time for those 55 patients receiving DCVax-L are more than 18 months, which indicates the new target of 4 months of benefit for patients receiving DCVax-L compared to those receiving standard of care in the ph3 trial is most likely achievable.
In addition, with the continued release of DCVax-D data, we will see a gradual and firmed trend of institutions increasing their shares!
The reason that there have been no look at efficacy at 66 events (or maybe 88 events) may be simply because the full enrolment number (240 excluding pseudo ground, 310 total, or now about 330 after the recent announcement of expanding) had or has not yet reach at the time of 66th events, or 88 events!
The point is nobody knows what is really happening behind the public arena.
So from the perspective of investing, either betting the farm (unfortunately I am one of them) or sitting on the sideline type is risky: for the former the risk is losing all or half of investment money, and for the latter the risk is to miss out a potentially ten fold of profit.
at 9:30 Am
Yesterday: Symbol: NWBO
Today after that big sudden drop to $6.75:
Happy to continually see naked shorts. Last week is more than 2 millions, on top of more than 6 millions of short selling shares accounted.
I don't know when shorts get fried, but it will come in due course!
Continue communicating with shareholders, patients and the public with updated D trial information;
Come up something definite with L trial
All others serve as bonuses!
at around $7.3 ~ $8.3 or at a higher price next week or so!
Fact: DCVax-D has been shown to be a very promising treatment for cancer patients, which has the potential of replacing Chemo, that is the reason why that corrupted Pakistani Doc from MDA talking to AF in the first place.
Noise: There would be noises and attacks from anyway in ang angle before DCVax become standard of cares for cancer patients. Linda just shows us what is the best way to deal with it.
As investors of this company, we should all be proud of what we have done. The ever-increased attacks are just indicator that we are near the finish line to become the champion in cancer treatments, which making opponents desperate!
Pray for patients to have a cure!
cited from ECYT February 24, 2014 Annual Report:
"[Omitted] Patient enrollment remains on track for the Phase 3 PROCEED registration trial of vintafolide and
etarfolatide in ovarian cancer, and we expect enrollment of the 250th patient in the targeted FR(100%) patient population in the second quarter; evaluation of interim results by the independent data and safety monitoring board (DSMB) will determine whether the final 100 patients are enrolled. If the progression free survival (PFS) hurdle is achieved, they will recommend the enrollment of the final 100 patients. Because the PFS hurdle at this interim analysis is similar to that required for a positive result at the end of the trial, achieving this hurdle will increase confidence in achieving the primary PFS endpoint. [Omitted]"
Well, that interim report did come in time as expected on 2 May 2014 which recommended stop the trial for futility, and Marck and Endocyte did so accordingly.
Now remembered that NWBO reached its first interim event (66 patients in last Dec), and we have since been waiting for any recommendation based on efficacy review of that interim analysis. Recently, Linda hinted that the company was internally actively considering adding "a little bit" of more patients to the ongoing trial, and she did follow through as reported in a news release. As a result, several more sites in US and one site in Germany are opened.
Well I don't want to say anything more. Please draw your own conclusions !
BTW, I love the results from DCVax-D, which will be much more broad and extensive than DCVax-L!
From a SA blog:
"3 Biotech Stocks Making Big Gains On Big Catalysts 0 comments
Jun 17, 2014 11:14 AM | about stocks: DARA, ICPT, MNKD, NWBO
Northwest's stock has been all over the map in the past few months, recently falling down to the $5.50 trading area, but today the company released some very impressive data from their DCVAX-DIRECT trial that sent shares roaring to the upside. "In the ongoing Phase I/II clinical trial of DCVAX-Direct for all types of inoperable solid tumors, all 9 out of 9 patients who have received 4 of the 6 planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization (i.e., stopping the progression) of their advanced cancer. In addition, in 3 of these 9 patients, biopsies now showed no live tumor cells in the injected tumor." MD Anderson, who is conducting the trial, is one of the premier centers for cancer drug development in the U.S.
The news released today is a major catalyst for the stock, and it is expected that the company will be releasing further updates soon. Some investors even expect that updates could begin coming on a weekly basis as the trials progress. In any event, the news today is very big for Northwest and investors should take notice of it. Although it is still early, the last news released of this magnitude from a company was when Intercept Pharmaceuticals (ICPT) announced the early stoppage of their FLINT trial due to overwhelmingly significant improvement in January 2014. The same could happen for Northwest, and investors probably know the kind of gains ICPT made on their news. Some investors believe the news is even bigger and better than the news ICPT released when its stock soared over $440.00 a share. Northwest could make a similar run with huge gains, and investors should keep a close eye on developments as they are made public."
Having wait for so long, I don't mind of waiting a little bit longer!
Of course I am here and will stay as long as at least seeing DCVax platform is finally validated in the US. I have kept adding shares and call options all the way as of last week.
Pray for patients!
Anyone can assume I am still here and I am still here long and strong. Increasing my shares all the way!