NW Bio receives recommendation to continue with Phase III GBM brain cancer trial based on the DSMB's Safety Review. Dr. Marnix Bosch states "We are pleased with the recommendation of the DSMB to continue the trial as planned. This is an important step in the ongoing progress of our Phase III tria
This early access approval goes substantially beyond the scope of the ongoing phase 3 trial which is studying DCVax-L only in newly diagnosed glioblastoma multiforme (grade IV glioma) patients. The exemption allows DCVax-L to be provided not only for this indication, but also for lower grade (less malignant) gliomas. It also extends beyond newly diagnosed gliomas (actually glioblastoma multiform) that are the focus of the phase 3 to include recurrent gliomas. The early access to DCVax allows patients to receive DCVax-L for all cases of glioma. This is stunning.
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Adam : I asked PEI.
"The Paul Ehrlich Institut signed the letter (Bescheid) on 14th February and we publish the approval in the Federal Gazette with date of 21th February. That is the date when the letter has been handed to Northwest Biotherapeutics," said PEI spokesperson Susanne Stoecker, in an email.
The only manipulation that has occurred in this case is Feuerstein's use of the date of just the first step in the multi-step process to distort the facts about NW Bio's announcement and its timing.
Feuerstein's article also raised assorted additional speculative and misleading claims relating to the Company's clinical trial program. The Company reiterates that its Phase III trial is on track, and it refutes those Feuerstein claims as well.
NWBO is not working for him, Not for sure his day trade activity, Not for his Moron thoughts assumptions and conclusions. They have certain SEC obligations to protect the investors interest and company from litigations.
NW Bio prepares for large-scale manufacturing expansion
29-Jan-2014 - Northwest Biotherapeutics has agreed with CMO Cognate Bioservices to begin a large-scale expansion of the manufacturing, storage, handling and distribution of its personalized immune therapies for solid tumor cancers.
Cognate is a world leader in such developments, with an unparalleled 12-year track record of regulatory and operational success with two dozen different cell product trials, and with clinical grade manufacturing of cell products on 3 continents.
20-Nov-13 18-Feb-14 Increase
Top Institutional Holders 49% 61% 24%
Cognate 5,600,000 8,500,000 52%
Toucan Capital Corp 5,400,000 5,100,000 -6%
Franklin 2,200,000 2,200,000 0%
Heights Capital 2,100,000 100%
Sabby 978,400 2,100,000 115%
Mehiel (Dennis) 2,300,000 1,800,000 -22%
The Vanguard 372,700 713,300 91%
Goldman Sachs 620,700 100%
Whitebox 281,700 548,400 95%
Royal Bank of Canada 408,200 518,200 27%
Do you really think Goldman Sachs would invest $3.2 million dollars
620k shares of NWBO if they thought there was a chance there wasn`t positive news coming. and Heights Capital 2,100,000 shares 100% Increase=$10,500,000 million last two weeks!
Come on People our few thousand shares is nothing compared to what institutions have at stake. They would Not invest that kind of money unless they had solid information. First they had to get the price over $5.00 before they could BUY that many shares and risk that much money. We have a Winner!
Goldman Sachs is new institutional investor in NWBO. it was not there early Feb. 620,700 shares
NWBO shall treat him like a street dog...
Can you just stop BS to people that you have problem that you and your short buddies are toasted.
Thanks....I cannot imagine delay in PR about German PEI =FDA approval MEANING there is problem. Adam think he has more knowledge then ALL AUTHORITIES & DOCTORS
One way to find out would be to know the exact date on which the Paul Ehrlich Institut (PEI) -- Germany's equivalent to the FDA -- informed Northwest Bio about the DCVax Hospital Exemption decision. If the approval was granted last week, then the Friday-Monday press releases from Northwest Bio would make sense. If the PEI decision came earlier, it would be reasonable to suggest Northwest Bio was trying to manipulate the news.
Question : Why do you care on what date and why delayed? Bottom line is GERMAN FDA has granted Approval aand that is the fact - Also delay doesnot make sense to conclude that there is problem with P-3 clinical trials as Data Monitoring committee already said to continue trial.
Why do he care the NWBO got PEI approval Letter yesterday or 22nd Feb 2014.
He only care that NWBO Gone way up then to cover for his shorties. So TIMING ? Yes Adam and his bander logs got trapped.....
Height of STUPIDITY COMES WHEN MAN GETS MOST NERVOUS LIKE ADAM
Now bluffing and Bluffing and Bluffing
1. AGEN in Russia has nothing to do with German PEI
2. Delcath Systems (DCTH_) received in CE Mark approval for its liver cancer therapy in 2011. ...AF Stupid shall know that this is Treatment Devices and not for Therapeutic Injectable Drugs.
All made in CHINA Devices also gets CE mARKS DOEN'T MEAN APPROVAL BY GERMAN PEI FDA
He knows more than GERMAN FDA on how DCVax benifits patients ?