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Mar 7 • 3 tweets • 2 min read
Relatively New Program at FDA:

CDER’s Accelerating Rare disease Cures (ARC) Program via @YouTube

$NWBO #DCVaxL #GBM #orphandesignation
Accelerating Rare disease Cures (ARC) Program

CDER's ARC Program | Center for Drug Evaluation and Research (CDER)

fda.gov/about-fda/cent…
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fda.gov/media/160996/d…

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More from @biosectinvestor

biosectinvestor Profile picture
Dec 21, 2022
$NWBO #DCVaxL

Interesting given some additional information in attached documents to that page, which I will include below this as a thread.

UK NICE updated status:

"DecisionAwaiting decision"

nice.org.uk/guidance/topic…
"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."

nice.org.uk/guidance/gid-t…
Read 13 tweets
biosectinvestor Profile picture
Nov 25, 2022
Exploring Adjuvants with #DCVaxL: POLY ICLC TLR 3 Agonist adjuvant discussion, #DrLindaLiau, early trial P 1. Using adjuvants w/ #DCVaxL $NWBO #Murcidencel #DCVax

Survival Data w/Adjuvants, small early trial:
Fuller Discussion re early trial with #DCVaxL + adjuvants, including Poly ICLC:
Re single agent checkpoint inhibitors, without DCVaxL, in Glioblastoma:
Read 13 tweets
biosectinvestor Profile picture
Aug 12, 2022
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.
Read 6 tweets
biosectinvestor Profile picture
Jun 22, 2022
Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View - ClinicalTrials.gov

#AdjuvantStimulus #PolyICLC

Ongoing #DCVaxL trial with Adjuvant stimulus, will likely further improve outcomes with #DCVaxL $NWBO clinicaltrials.gov/ct2/show/NCT01…
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
Read 7 tweets
biosectinvestor Profile picture
Jun 21, 2022
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.
Read 32 tweets
biosectinvestor Profile picture
Jun 5, 2022
$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.

Quote:
Read 20 tweets

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