His presence at this news conference was a significant sign of support and probably one reason why it was so high profile, at least locally. #DCVaxL $NWBO #BrownUniversity
Lifespan WPRI News Conference, Jan 6, 2022 Transcript
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"Timing Issues...
Given the current absence of phase III trials for DCVaxL but the pending results of a phase III RCT trial, this NICE single technology appraisal would be better completed following publication of that study."
..."Comment noted. NICE aims to publish guidance on cancer drugs within 90 days of marketing authorisation. Any requirements for potential delays will be taken into account as appropriate."
Al Musella, President, Musella Foundation for Brain Tumor Research & Information, Inc., a 501(c)3 nonprofit, re #DCVaxL : “ The results are outstanding.
Over 200% increase in the 5 year survival rate for newly diagnosed Glioblastomas as well as in the 30 month survival for recurrent Glioblastoma. There has been some unfair criticism of the trial on the internet -but watch the video and get the details directly from the source!
The same criticism happened after every major trial for brain tumors this century.
A trial with a combination #DCvaxL#PolyICLC and #Keytruda is already in process at UCLA. This is some of the early research on that combination $NWBO $MRK
Some quick thoughts on $NWBO and #DCVaxL. DCVaxL is designated an #OrphanDrug, for an #OrphanDisease, #Glioblastoma. This provides a bunch of benefits which are off topic for this thread.
My main point is to suggest that patients needing #DCVaxL may likely qualify for either of two funds in the UK, the #InnovativeMedicinesFund or the #CancerDrugsFund, which together have £640M allocated to provide early coverage to patients in the UK's NHS.
The UK charity, BrainTumorResearch.org recently put out a PR about the new program in the UK for rare diseases, which is modeled on an already existing program called the #CancerDrugsFund.
$NWBO never unblinded: 3/31/17 Opinion, Judge George J. Hazel, US District Court of Maryland, Southern Division, Motion to Dismiss, Granted - “Plaintiffs' additional argument that Defendants were trying to "bury" interim efficacy results is undercut by the record itself.
A review of the record in its entirety leaves as the only reasonable inference that the data monitoring committee had reviewed only safety data from the Phase III trials, not efficacy data.”
casetext.com/case/lerner-v-… Federal District Court Decision, Chad A. Lerner, Plaintiff vs Northwest Biotherapeutics, Defendant, p22.