Example : if adams wife is expecting -before 9 months finished or about to. Can i ask adam to tell me he is boy or a girl - not then its a still born !!!
Do not worry about Adam he is trying 4% retails but this would go $20 ++++
Northwest Bio CEO Discloses More Problems With DC-Vax Brain Cancer Study!!
If there is a significant difference between two groups at alpha = 0.05, it means there is only a 5% But 0.02% MEANS ONLY 2%...and that has been achieved according to Linda Powers....
When statistically significant results are achieved, they favor rejection of the null hypothesis, but they do not prove that the null hypothesis is false. Likewise, non-significant results do not prove that the null hypothesis is true; they also give no evidence of the truth or falsity of the hypothesis the researcher has generated.] Statistical significance relates only to the likelihood that results obtained were not due to chance.
Adam is trying to take help from retail traders by issuing negative PR soon NWBO jumps, STOPLOSS on Short covering that makes Adam more panic as he remained SHORT and FLOAT remains very low. Yesterdays 3.3Million shares trade would have taken NWBO to $10 to $20 however Adam put another SHORT in most of these volume to keep Price as low as possible.
Institutions 35 Holders
Mutual Funds 14 Holders
Other Major Holders 18 Holders
Points Adam made are worthless ( Number Patients, Interim Results...etc...) he pretend to know more than LINDA at the same time he also knows that DCVax already got Germany PEI = USFDA Approval, DMC decision is due anytime. He is trying to provoke Linda to disclose public information but also knows she cannot at this time. Adam is .....Nut
Shareholders Top Shareholders
Large Block Owners 53
Total Number of Shares Held 26.3M
Buyers 3/27/14 10,490,606 $39.96 43.6%
Sellers 3/27/14 1,158,173 $4.25 17.4%
Cognate ... 8.5M $27,659,005 +32% 19.7% Low
Toucan Capital Corp 5.1M $16,573,666 +19% 11.8% Moderate
Franklin ... 2.2M $8,196,523 +8% 5.0% Low
Heights Capital ...2.1M $9,874,998 +8% 4.8% Low
Sabby ... 2.1M $7,744,334 +8% 4.7% High
Mehiel (Dennis) 1.8M $6,804,718 +7% 4.2% Low
The Vanguard ... 713.3K $2,688,983 +3% 1.6% Low
Goldman Sachs & ...620.7K $2,340,039 +2% 1.4% Moderate
Interim results shall be out anytime but an indication is good enough if she pulls out rabbit from her hat!
If that would have been case she would have cancelled the presentation, ....But better be ready for the Biggest Surprise of this year.
Also note the point that Phase3 Trials started in 2006 and we are almost approaching the conclusion which is due in Sept 2014. Mean while DMC already informed to continue the trials which means that there were no safety issues involved, If STANDARD OF CARE - Overall Survival is just 14.5 Months then we already crossed that on 88th Event since beginning of trials. What it ultimately means that - DCVax-L has OUTSTANDING results just waiting to announce. Interim results are Out ONLY IF Trials needs to be stopped where results are either NOT showing and better efficacy or otherwise Safety issues. In both circumstances if DMC RECOMMENDING to continue trials means DMC of the opinion that - TRIALS NEED NOT TO BE STOPPED on Safety or Efficacy.
$20 or more with coming PR- with DMC interim analysis of the assessment recommendation that the DCVax-L has met efficacy and unexpectedly high levels of success.
he most common DMC recommendation is to continue the trial as originally planned, although it is possible in rare instances that the DMC may recommend that the trial be stopped, either because of safety or futility concerns or because of unexpectedly high levels of success. The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded
First interim analysis of NW Bio's international Phase III trial is 66 such events, comprising 60% of the 110 events required to reach the primary endpoint of the Phase III trial. Another interim analysis will occur when 88 events, comprising 80% of the total 110 events, have been reached.
As is normally the case, this interim analysis of the Company's Phase III trial data is being conducted by an independent Data Monitoring Committee (DMC), with assistance from the independent CRO (contract research organization) managing the trial. The independent CRO audits and confirms the raw data, and delivers it to the DMC. The DMC then reviews and evaluates the data and reaches an assessment, which it delivers to the Company. The most common DMC recommendation is to continue the trial as originally planned, although it is possible in rare instances that the DMC may recommend that the trial be stopped, either because of safety or futility concerns or because of unexpectedly high levels of success. The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded.
Due to the work involved in auditing and preparing the data, and conducting the review, it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now.
Summer Street analyst Carol Werther reiterated a Buy rating and raised her price target on Northwest Biotherapeutics (NASDAQ: NWBO) from $10.33 to $15.10 earlier, following news yesterday Germany has approved DCVax-L, a glioblastoma multiforme (GBM) vaccine, for an early access program.
"This is very strong endorsement from the German government," Werther said.
All data collected to date will be already surpassing STANDARD OF CARE 14.6 months Survival Rate and this in fact for use in the trial’s overall survival results, and which includes the following:
Conclude the FDA Designation as a Phase III trial and could result a direct approval
Expanded and enhanced statistical endpoint analyses
DCVax-L is the first product of its kind to receive Hospital Exemption early access approval from the German regulators, in the following key ways:
• the first immunotherapy;
• the first product which exerts pharmacological (drug-like) effects in the patient's body;
• the first product that has never previously been on the market commercially;
• the first product developed by a non-German company, not previously under the German regulators' oversight; and
• the first "somatic" cell therapy product (a somatic cell is any cell of the body other than a reproductive or embryonic cell).
What is the Investment Importance of This?
This is a stunning coup for Northwest Biotherapeutics. While the phase 3 trial will still need to be completed and be successful in order for Northwest to obtain a full approval and marketing authorization for DCVax-L, it is extremely encouraging that one of the world's premier regulatory agencies believes that clinical data created before the phase 3 trial is sufficiently convincing to make DCVax-L available on an early access basis for all glioma patients. This is an extremely positive validation of the product and also of the manufacturing and infrastructure that is in place for producing, handling and distributing the product.
GBM brain cancer patient treated with DCVax-L celebrates 10th anniversary of cancer-free survival
GBM is the most aggressive and lethal form of brain cancer. With today's standard of care (surgery, 6 weeks of daily radiation to the brain plus daily chemotherapy, followed by monthly chemotherapy), this cancer typically recurs within 7 months and kills within 14.6 months. Without all these treatments, GBM typically kills within months of diagnosis.
When Brad was diagnosed, he was told by his doctors that he had only about 2 months to live.
Brad is now the second patient from the Phase I/II trials with DCVax-L for GBM who has surpassed the 10-year cancer-free survival mark. The first such patient has further passed the 11-year cancer-free mark.
Beyond these two 10-plus year survivors, the long-term follow-up data on the other patients from the Phase I/II trials shows a "long tail" of survival among them. The median survival of GBM patients treated with DCVax-L was 3 years (in contrast to only 14.6 months median survival with standard of care). The "long tail" also stretched significantly further, beyond this median: 33% of the patients reached or exceeded 4 years of survival, and 27% of the patients reached or exceeded 6 years of survival (in contrast, only 3% or so of GBM patients are still alive at the 5-year mark with standard of care treatments). Several of these patients are continuing to move through further years of survival.
Common sense prevail more than asking DSMB About efficacy from person like Adam...
Glioblastoma multiforme (GBM) is a primary brain tumor with a median survival of 14.6 months postdiagnosis. The infiltrative nature of GBM prevents complete resection and residual brain tumor cells give rise to recurrent GBM, a hallmark of this disease. Recurrent GBMs are known to harbor numerous mutations/gene rearrangements when compared to the primary tumor, which leads to the potential expression of novel proteins that could serve as tumor neoantigens. We have developed a combined immune-based gene therapeutic approach for GBM using adenoviral (Ads) mediated gene delivery of Herpes Simplex Virus Type 1-thymidine kinase (TK) into the tumor mass to induce tumor cells' death combined with an adenovirus expressing fms-like tyrosine kinase 3 ligand (Flt3L) to recruit dendritic cells (DCs) into the tumor microenvironment. This leads to the induction of specific anti-brain tumor immunity and immunological memory. In a model of GBM recurrence, we demonstrate that Flt3L/TK mediated immunological memory is capable of recognizing brain tumor neoantigens absent from the original treated tumor. These data demonstrate that the Flt3L/TK gene therapeutic approach can induce systemic immunological memory capable of recognizing a brain tumor neoantigen in a model of recurrent GBM.