Replies to post #737562 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

I think they over exaggerated the link between the time to MAA determination and potential denial. If they did any due diligence on typical time frames they would know there's no correlation between time and acceptance/denial and that we aren't currently overdue.

[meirluc]

Plenty wrong with the SA article which was trying to be subtle but failed miserably.

1. "DCVax-L demonstrated an improvement in median overall survival (19.3 months
vs. 16.5 months), which was statistically significant, in the newly diagnosed cohort.
In patients with recurrent disease, median OS was 13.2 vs. 7.8 months, which was
also statistically significant."

No additional SA comment about the mOS that was statistically significant for the rGBM
(crossover ) group? What an understatement concerning the unexpected, spectacular
positive mOS results demonstrated by the 64 crossover patients. This was a clumsy SA
effort to bury the most outstanding results of the phase 3 trial. Witness the ongoing
UCLA trials that are attempting to fortify DCVax-L (via addition of poly ICLC, keytruda)
as a treatment for rGBM patients. That highlights the potential of increasing DCVax's
capacity to treat rGBM patients and it was completely ignored in the SA article.


2. "Unfortunately, there are very real questions about the efficacy of DCVax-L, and if it
wasn't in glioblastoma, we probably wouldn't be having a conversation about whether
the issues related to the phase 3 trial are enough to consider."

Nonsense. for both nGBM and rGBM patients, DCVax-L demonstrated a statistically
longer mOS than did the comparable ECA groups. Also 13% of the DCVax-L treated nGBM
patients survived more than 5 years whereas only an estimated 5% of the comparable ECAs
were 5 year survivors. Furthermore after progressing, the 64 DCVax-L treated crossovers
had a 5.4 months longer mOS than did the comparable ECAs (13.2 vs. 7.8 months).


3. "Moreover, progression-free survival actually appeared worse in the DCVax-L arm
(6.2 vs. 7.6 months), although this was not statistically significant.

Really? The median survival time of the 232 nGBM treatment patients between the
phony mPFS of 6.2 months and their mOS of 19.3 months was 13.1 months (19.3-6.2=13.1)
whereas the equivalent survival time of the comparable ECAs was only 8.9 months
(16.5-7.6=8.9). This obviously strongly suggests that the mPFS of the 232 nGBM treatment
patients was confounded by pseudo-progression and was most likely considerably longer
than 6.2 months.


4. "NWBO has not disclosed receiving a letter of concern (an RFI) that would require more information"

I do not believe that companies submitting an MAA to the MHRA are required to tell their
shareholders whether or not they received an RFI.


5. "Approval is still possible, even though the review is taking longer than the company would like."

Is there any data indicating that the longer it takes the MHRA to review a MAA, the less likely it is
for the MHRA to approve the application?

SUMMING UP: NICE TRY BUT NO CIGAR