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What I stated was that the SEC (per regulation FD) defines selective disclosure so as to include disclosing via phone calls.
If you disagree, take it up with the SEC.
More bashing from a blogger.
She Expresses Concerns about the Phase 3 Trial Design
Dr. Liau has expressed concern that the endpoints of the trial which are based on mPFS (primary endpoint) and mOS (secondary endpoint) are not appropriate for measuring the long term benefit of DCVax-L. These median endpoints are reached in months and the effect of DCVax-L is established over two to three years. At the median times, its effect may not be apparent.
She also expressed a concern that allowing patients in the control group to switch to DCVax-L after their cancer has progressed could confound the analysis of median overall survival.
Could the Phase 3 Trial Fail to Reach Its Proscribed Endpoints?
There are many examples of drug studies which fail because of the trial design even though the drug is eventually shown to be effective against a disease. There is a possibility that the phase 3 trial of DCVax-L might not be successful because of these trial design issues.
Could DCVax-L Still Be Approved if the Trial Fails to Reach its Proscribed Endpoints?
If DCVax-L does not achieve its primary endpoint of median progression free survival and if the cross-over allowed in the study obscures the effect on overall survival, does this mean that DCVax-L would not be approved? This is a very real possibility. The FDA is exceedingly stringent on insisting that proscribed endpoints be reached in a trial in order to gain approval. It virtually never allows a Company that has conducted a failed trial to go back and look at how different subsets of patients fared or whether the trial would have been successful if some other endpoint had been used. This type of analysis is called data dredging and the FDA in the past has in almost every such case rejected attempts to gain approval on this basis. The agency almost always insists on doing a new trial with new endpoints.
I would rather they just get the financing or EU deal over with. Stop the slow drip. Retail (at least those like me) are not buying the fade in price because of the financing overhang.
If/When a deal is done I expect the price to start a recovery. I will likely add on the open following such a deal.
Get the damn thing done [talking to OTLK, not you Thermo].
You mean like my bets on significant revenue in past years and approval by 2023 summer , 2024 august? I must have missed the news on those.
There is exactly one where I was surprised and admit being wrong. I did think they would not get into a JAMA level journal w/o significantly cleaning up the article. They did clean it up some (admitting to the efficacy IA and trial limitations), but I did expect more was needed.
How about some more important ones. That the trial had failed PFS. That the trial had failed OS with the randomized arm. That there really had been an efficacy IA in 2015 (which creates serious issues for endpoint change).
Feel free to actually go against me with some forward bets.
How about no MHRA MAA approval this year? No terms needed, just a friendly bet. Come on, step to the table.
Well, if the delay was for Eden, maybe they could have just stayed with CRL. They already have automated cell manufacturing systems from both Miltenyi Biothec and GE. Health.
https://www.criver.com/products-services/cell-and-gene-therapy-cdmo-solutions/cell-therapy-manufacturing/autologous-cell-therapy-manufacturing-services?region=3601
On the "worst CEO list", AF had M Shkreli one behind LP.
I think MS deserves number one. So have to disagree with AF on that.
Viagra.
Many forget exactly what M Shkreli got an orange jumpsuit for.
He had owned a hedge fund. The fund took over a public biotech. It used the cash raised through the public bio he controlled to fund his personal companies. He also created a huge pump/dump in the KBIO (or whatever the name was).
Can anybody think where else we have heard that story?
I have found no mention of the MHRA MAA submission time.
Takeda has disclosed the FDA submssion (March 2023, approved Nov 23), EMA submission (validated June 2023, approved June 2024) and the Japan submission (Sep 2023). Also the FDA review was under ORBIS so the MHRA and other Access RAs were sitting in on it.
FDA, EMA and Japan are the big 3 RAs. Both market value and that they are considered the leaders. That is why it is hard to hear much about submissions to others.
Articulate reply there DD.
BTW, are you still comfortable with your bet that MHRA approval wold happen by August 2024? From post 721109:
When the story shifts to future trials they need to set the new goalpopst to "soon".,
Expect the storyline shift as the days turn longer.
Well, Annie Post says it, so it must be true.
By Sep 28 either they announce approval or the MHRA had an issue and NWBO is appealing.
Thanks Anne.
So you are saying Dr Cloughesy,, the PI, does not know what he is talking about when he asserts the trial is not designed to establish efficacy?
Perhaps you can educate him on the subject.
They may well announce a combo trial in the next half year. They have announce many in the past after all (none of which launched). They might even launch one, though March might be a tough timeline for that.
But running a combo trial with Merck or such as a collaborator is not what people consider a "partnership" or "deal". And they do not bring in cash, just help to offset cost of trial.
There are literally hundreds of these combo CI trials with various small bios all over the map. Nobody cares much. Even NVCR has a couple:
EF-41/?KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (EF-41)
EF-36/?Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer (KEYNOTE B36)