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Got answer from LL regarding Pembro + DCVax L combo trial. They are half-way through recruitment and results are not likely until 2023.
Has this been discussed?
"In contrast, DC lysate In order to further enhance the efficacy of DCVax-L, a phase II randomized trial for recurrent glioma patients treated in combination with with DCVax-L in com- bination with with programmed death 1 blockade (NCT03014804) is underway." from Glioblastoma, Part II: Molecular Targets and Clinical Trials, Linda Liau (published April 2021)
DCVax-L + Opdivo (Nivolumab)
The order of events is data lock --> unblinding --> top line.
You cannot get top line data without unblinding the trial.
Why don't you do that yourself?
Answers from DI:
Asked him if he had any comments on Duffys exit. This was his answer:
"Offer he couldn’t refuse from Merck and changes nothing as to how we are proceeding. Kevin a very good guy who made some significant contributions when he joined and I am glad to have worked with him.
Our goals remain the same and his departure doesn’t change anything.
Data Lock
Unblinding
Top line
Sawston"
Furthermore, I asked him why data hasn't been locked so far.
His answer was:
"If all data isn’t in you can’t lock it".
Either his answer to the latter question is false or the remaining queries mentioned in a presentation has been taking forever.
How would they know without unblinding?
Comments from NWBO on the draft guidance:
https://www.regulations.gov/document?D=FDA-2019-D-4964-0065
Most likely referring to queries.
However it is not the case. SAP is not done.
I believe nobody on this board has any specific knowledge about what a fair amount of time spent on revising a SAP is.
My worries about the time spent so far might be wrong.
The DRAFT was completed last year, which was stated in the 10-Q.
If people follow this board and the posts regarding conversations/emails with DI, they would know that final SAP was not completed last year and is still not.
"When the company feels that the SAP is in good shape, they will do the datalock and unblind."
Hence datalock and unblinding are not the only tasks remaining. Regarding his comment on the SAP, he has told me the same. This is kind of a standard-answer he can keep on telling, without getting specific at all.
I do not know the standard response and implementing time for comments regarding SAP, however the time they have already spent seems a bit worrying.
Why do you believe SAP was done last year?
"The only tasks remaining are the datalock and the unblinding."
If that is true, it would imply that final SAP is done. What are they waiting for?
Unfortunately, it seems like there is still long way to go.
DI said, that they have not even decided yet, whether data lock/unblinding will be communicated.
If SAP is complete, why haven't they unblinded?
From my perspective, the only reason why unblinding has not happened is that they are still in dialogue with RA's regarding SAP.
Given the level of the posts, I really doubt that.
Then why are you spending so much time on this board?
I do not think anyone on this board is in doubt about your opinion.
Why keep on posting the same everyday?
Another classic comment. How many of these have you posted within the last couple of months?
"The fact that IT SEEMED LIKE..."
We'll see whether they announce it or not. Given the information we have from DI, no one on this board knows if it will happen.
I know unblinding follows data lock.
The fact that it seemed like they intend to announce it and DI will apparently be pushing for it does not imply that they actually will announce it.
I share your confusion.
I recommend sending an email to DI asking if management plans to communicate data lock. He might be able to clarify.
See my post: 254669
At that time, people were speculating whether trials had been unblinded or not. One simple email was enough.
He said he will be pushing for it to be communicated to shareholders.
He is actually willing to give some information in written form.
E.g. that unblinding had not happened.
The unblinding might be occurring right now
Why don't you ask DI? Last time i asked him, he actually answered the question.
Their communication could provide a lot more information than it does.
However, a large amount of the questions/speculations on this board could be answered/ended if people actually called or emailed DI. He is not willing to answer all questions, but at least some.
Well that does not agree with what DI told me in our conversation. First of all, it seemed like they intend to communicate when unblinding occurs. Furthermore, he said that TLD would not be immediately after unblinding.
So you do not expect an announcement of unblinding/data lock before TLD is released?
I get your point. However, a SAP is not formally approved by RAs. Hence some uncertainty about RAs attitude remains.
RAs does not "approve" a SAP. Unfortunately, NWBO will not get a response (e.g. FDA) stating that SAP is approved.
When they "fell comfortable" about the SAP, as DI said, they will move on to unblinding.
It would not make any sense with several different SAPs.
As someone mentioned (cannot remember who) several different SAPs will result in different results. Obviously, it doesn't make any sense that several RAs have to make approval decisions based on results that may differ based on where application is submitted.
I would be surprised if they announce TLD before February 2020.
Well it seemed like they are still in dialogue with RAs. When they "feel comfortable" they will lock data and unblind. Asked him how long it would take from unblinding till TLD. It seemed like it wouldn't be immediately after.
Well i do not think i stated that. I think DI meant a "full" 2019 blinded update.
I agree that number of patients alive should have been included.
DI told med, that they decided not to give update on 2019 blinded data, since apparently is a costly and time-consuming task. Guess they decided it it better to wait until topline.
Do we know when Bosch speaks?
I agree on that.