CDX- 1135. It is a soluble complement inhibitor that targets both C3 and C5. This drug was developed by Avant (acquired by Celldex) which called this drug TP10. It is a technology that is similar to that which Alexion has led to extraordinary success for ultra-rare orphan diseases with its lead drug Solaris; had sales on $2 billion in 2013 and Alexion currently has a market capitalization of $32 billion.
Last stock offering underwriters paid $24, Bristol's up-front payment was small relative to upfront payments made by big pharma and big biotechs in the past year, but the real benefit to Celldex is in the renegotiation of its license with Medarex and the potential to cozy up more closely with Bristol's promising oncology business.
The bottom line is this, the lead investigator for DCVax-Direct, Dr. Subbiah from M.D. Anderson, indicated early on that this DCVax-Direct trial would have a decade long impact on cancer treatment and the early evidence from this trial supports his assertion. The German PEI validation of the DCVax platform and Dr. Subbiah's remarks placed in the context of these early results provide more than enough evidence that a great deal of investment derisking has already taken place. Those who do not understand or accept this may be fooled into buying NWBO stock low and selling lower which is what momentum traders are prone to do when A.F. attacks come as a surprise. Others are waiting as you are for further validation. This will mean a buy in at a much higher price but with much more certain prospects. This represents a change in your investment strategy from when you were invested in IMUC before it fell so hard but in this context, readers will be able to understand that most of your statements are made in defense of this new investment position. There is absolutely nothing wrong with this as long as it is not being superimposed, as superior, upon other strategies that are just as valid.
Meaning of PR from MD Anderson is that - IN OPEN LABLE UNBLINDED STUDY - MD ANDRSON will disclose results only at the end of the study. But if company wants to disclose they can at their discretion and results are documented in patients file.
So were is REBUKE? What MD Anderson said is - It is Open Lable Unblinded Study where MD Anderson is not obliged to publish the results where as company can publish finding at their discretions.
Adam is well paid basher of bigger pharma and his agenda is slowly coming to light. Otherwise Why he should take so much interest. ADAM is deputed by Bigger Pharma to stop NWBO GETTING BIGGER LIKE AMGEN
I will request company to come out with PR every week on each and every patients, and no matter what- Even if it is cheery picked patients. Who cares if patients cancer is getting cured.
OPEN LABEL UNBLINDED STUDY ADAM - You don't scoop too much, company can disclose patients to patients report and that's what they did, Sleepless nights ahead for you.
ADAM cooked many statements and thank that MD ANDERSON PR do not say what ADAM claimed.
It is OPEN LABEL UNBLINDED STUDY RESULTS are disclosed on every progress it makes NO NEED TO HIDE and who cares what Adam has to say but trials are in place and its working.
MD Anderson may report upon completion of study but NWBO can report anytime they want.
MD ANDERSON - is a platform used to conduct the trials and if the Interim results are good and documented in their records and if NWBO has access and privilege they can report to the public. MD ANDERSON is not obliged to disclose but company can.
it is neither unusual nor inappropriate for interim results from unblinded, open label trials to be reported, particularly in the case of a novel technology in a particularly difficult disease setting that is the subject of significant scientific, clinical and public interest. In such cases, both companies and researchers frequently provide interim data and/or case studies.
Dr. Buzdar never made any of those statements which Adam writes in his PR.
First PR - Adam writes....
But Buzdar said investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study.
PR from MD Anderson on Dr. Buzdar
Dr. Aman Buzdar, MD Anderson's Vice President of Clinical Research, explained to the news outlet that the standard practice for clinical trials is that data only be released at predetermined time points defined by the research protocol or at the completion of the entire study when data are fully analyzed.
Dr. Buzdar has no associations or financial interest with this company or any other pharmaceutical company. Nor does he serve as a consultant or scientific advisor for any company.
MD Anderson was not involved in the decision to disclose the study information prior to the completion of the research. Therefore, we felt it was important to state that fact. We also felt it was important to state our belief that releasing incomplete research data is not accepted practice in our field.
After Phil Baumann was diagnosed with glioblastoma, his family began raising money for brain cancer research at MD Anderson. “When we hear that the money has helped more patients, it's a feeling like no other,” says Phil’s wife, Misty. “Excitement, thankfulness and happiness -- it's like 10 Christmas mornings all rolled into one.”
Dr. Mark Roh, President of MD Anderson-Orlando, states, "We are very excited to be joining this clinical trial to further advance cancer care and possibly expand treatment options to cancer patients. Our oncologists and staff are dedicated to providing our patients with every opportunity to fight their disease, and being a part of this trial will give additional research options to the brave men and women who walk through our doors."
I understand that NWBO will work with M.D. Anderson to respond to this latest Feuerstein missive. I do not see this as an important new event in the DCVax Direct trial. It is an article composed by an author will a well laid out and well understood negative agenda.
Although this is a sensational headline, it does not in anyway impugn the data that has been released about DCVax Direct nor the possible final outcomes. It is a typical strawman argument about whether it is appropriate to discuss interim data. Opinions may differ, but what NWBO has done is not unusual or unethical