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The actual approval decision just lists 2 trials, DCVax-L for nGBM and for rGBM patients under 18 and at least 6 pounds. No more detail.
I am also curious if the assertion that the PIP trial(s) must be launched is true.
All I see in the PIP is that they were granted a deferral and that the PIP is complete summer 2028.
EDIT: Thanks flipper, missed that. So it says they do not have to be initiated prior to submission. Where does it say prior to approval?
CO's share count number comes from OTCMarkets site which gets it from compushare which is the registra for NWBO (and many others). It is accurate.
What is not know though is how may preferred shares that can convert to common have been issued.
There are 4 milestones to be paid by NWBO to former Flaskworks. The first has been paid. Crickets on the rest, and as stock payouts they are a mandatory disclosure.
At the 2022 ASM (where did that 2023 ASM go anyway?) LP said how they were testing various very different processes with Eden. That should be a clue that it could not just reproduce the existing process. And further they were to select a version to proceed forward on last year. Crickets there too.
People might look at the hundreds of millions that others have been poring into R&D in this field and wonder if Flaskworks is really special.
I would instead look at this site
Yeah, those curves were odd. Compare to any curves with Stupp, they do not fall off the cliff like that. They all tend to show some tail even if thin and short.
Wonder f that might have anything to do with post progression care in Russia?
Thanks for the info on the paper.
Agreed it does not mean anything of significance for NWBO. MRK will pay whatever they decide (negotiate) to pay for whoever they decide to buy.
Shortbread makes crumbs too
Sure pall.
Show me where MHRA has said anything about this imaginary SWIFT program. You can't, because it doesn't exist.
Some have used the adjective swift to describe efforts by the MHRA to move faster. That is fine. But if you are asking about any specific program or details that have never been announced have fun.
I am sorry if fail to grasp that swift is just an adjective.
Thank you Frank.
What normal dev stage biotects say at this step: Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)
Weee.
The preprint that has been disclosed is on interim data from an early 2023 data snapshot. There is no reason that would need to wait for the primary completion.
A paper based on the primary completion will be a different paper, Most likely at least a year or more away.
I missed the KM chart in 232 vs 99.OS
Can you please ink it?
You want to make up hypothetical explanations for the 233-99 OS number anomaly.
The simple question is why does NWBO not disclose and explain it? Why do they need you to push the storyine on the key data?
The failure to disclose the current SAP secondary endpoint of OS between the 232 vs 99 is "telling".
Some longs argue it does not matter. They are way wrong.
Some realize it is actually key, but assert it could be good. They are delusional. If that data was even trending well LP would have been shouting it from the tree tops.
The most important data sucks. And is not being being disclosed for that reason.
Hey, you have iinfo on the "true up" trial and aren't letting us know?
Not that I think the trial matters much Courts really do get into this type stuff much. And even it it does, would only mean LP/G give some options back that they can always re-issue later
But it is a trial. And it has been quite a while since NWBO has been involved in a clinical trial, the other ones that have new information.
Seriously? The OTC is not registered under section 6 of the Securities Exchange Act. That means they are not a National Exchange.
This is the list, per the SEC
Everybody knows the OTC has far less disclosure rules by law.
As far as the reason for NWBO delisting, that is pure crap. They were subject to 2 delisting notices at the time the fled.
The NWBO 8K on the subject