I like biotech. Focus is cell therapies, immune modulation. I tweet about stocks generally that I hold, including $NWBO
2 subscribed
Jun 23, 2023 • 12 tweets • 4 min read
I think one way to think of $NWBO's vaccine as DCVax being a platform, #DCVaxL and #DCVaxDirect are descriptions of instantiations of DCVax. the patient's dendritic cells, One w/a lysate, in vitro, the other in vivo to the inoperable or metastatic tumors, by direct application.
If #DCVaxL is approved, & #DCVaxDirect is a less complex expanded patient dendritic cell infusion of the same sort, processed but substantially not genetically or otherwise modified, one has to wonder how much complexity should be involved in its ultimate "approval"?
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."
Survival Data w/Adjuvants, small early trial:
Fuller Discussion re early trial with #DCVaxL + adjuvants, including Poly ICLC:
Aug 12, 2022 • 6 tweets • 2 min read
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!
Jun 22, 2022 • 7 tweets • 5 min read
Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View - ClinicalTrials.gov
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.
Jun 5, 2022 • 20 tweets • 3 min read
$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.”
#DrLindaLiau, principal investigator for a Phase 3 #DCVaxL trial recently gave a lecture covering the #DCVaxLComboTrial with #Keytruda.
2/ $NWBO and UCLA have a patent application pending approval for immunotherapy combinations with #DCVaxL.
Mar 19, 2022 • 14 tweets • 4 min read
Let's explore a new accelerated pathway to licensing for new drugs in the UK #MHRA#ILAP
The MHRA Innovative Licensing and Access Pathway is open for business
The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). #MHRA#ILAP
$NWBO #DCVaxL With regard to Dr. Roger Stupp being a consultant at $NWBO as they move toward the reveal of their top line data for Phase 3, publication and application to the FDA for approval, the BLA, adding him to the team I think is quite significant.
I made these points with other investors, so am sharing here.
2 subscribed
