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Speaking of N Malik, there is confirmation from a heavy long that he was running shares for NWBO on the side as he was publicly pumping for NWBO as a supposed independent analysts.
Sukos, the term "franchise" is used in the space to refer to a drug that is a significant portion of the company's business. It has nothing to do with opening McDonalds.
The July 9 approval PR revisited. It's so solid in detail and information that I (really) enjoy reading it every once and a while.
Five decades? Does your terminal use tubes and a CRT display?
Just 😂 ng. I cannot even recall what I was doing that long ago.
Welcome back though.
Can somebody sticky ATL's post?
Hi brad. A question.
When you argued 10 years the was no FDA hold on screening for the trial and it was an AA in the works, how were you so wrong?
Why did you not know it was an FDA screening hold that started the process?
Why on earth would anybody think an AA was in process?
A decade of pumping by you and the price has gone from about $6 to $0.60. Well done!
The last NICE update was in Dec 2022 when they assert:
They have not filed in the EU as far as we know.
An EU (EMA) approval would served as the basis for a UK MHRA approval. Previously this was based on the "Reliance Procedure"
Approx 1.7B shares.
In addition to warrants, options and converts there are also a few deals such as Flaskworks that would have to pay out.
And citing published data by Dr Liau does not imply any coorperation with MRK as being implied.
I think I got it.
They said they could not determine psPD vs PD. But then they had another endpoint that could. But they never presented that. And never said cPD was used to establish the rGBM arm.
Between your theory and Bio's about treating patients different based on randomized arm I am truly lost.
Maybe somebody should ask LL ( who unlike the other L we can trust)
PsPD is generally within 3 months from end of RT+chemo. The trial only waited 2 weeks from then.
As far as other arms, whatever. The screened over 1500, could create plenty of other arms.
No, that is wrong.
psPD typically shows up weeks to months after the end of RT+Tez. The baseline screening for catching rapid and pseudo progression is 2 weeks after the end of chemo.
The trial protocol is in the JAMA paper if there is any doubt on that.
The EU patent potentially has some value.
The first issue is that it only has value if a DC vaccine (-L or Direct like version) pus checkpoint combo is approved for gliomas. If that does not happen the patent means nothing.
Second, nobody knows the ownership interest in the patent. It was assigned to UCLA and 3 of LP's companies (NWBO, Cognate and Revimune). For the 3 LP companies she could put the ownership under any shell. Longs will say that it is NWBO, but there is no basis for this. Any or all or possible. Also unclear about the UCLA interest.
The former issue will not be resolved for many years. One would expect LP to PR the patent upon issuance if NWBO does own it.
I guess there must have been solar eclipse in 2017 and 2023 so no need to check for the shadow.
You do understand the DCVax-L is not an established medicine?
This change you quoted refers to MAAs submitted for generics and biosimilars, Previously those had a very long time to get approved which looked odd. Sounds like the problem was that they were not validated (unlike novel drugs which have been). That caused many incomplete application to start the clock and screw up the MHRA stats.,
Means nothing for the DCVax-L submission. That either has or has not been validated, but the process started last year.
For the FDA, they inform the sponsor of concerns as they arise. That allows the sponsor to fix minor issues on the fly. If a NDA/BLA is rejected (CRL'd) the sponsor will have heard of the reason in advance.
But the FDA may raise concerns that are borderline, in which case the sponsor may not know until the final action. In that case the sponsor gets the notice (approval letter or CRL) and it is up to them when it is made public. I do not remember the Martha Stuart story well enough to know if they sold after the CRL or not.
The EMA is a lot more formal. I think the sponsor is updated at specific times, such as the cock stop and CHMP meetings. But really do not follow them close enough to be certain of details.
I have no clue about the MHRA. Would suspect somewhere between the other 2.
More on the "formula"
What is being asked for is an explanation of how NWBO calculated the prices they sold stock at. Per the R&R:
Yes.
The formula they need to provide is for each of the NWBO listed sales how the price was calculated in a way that depended on the closing price on specic dates. Dates that were sometimes in the future.
I see no way this can be. And reads like the Judge who wrote the R&R was also a bit skeptical if you go back and read.
30 days. At least we have a real timeline.
Disagree with you on the law point, but more material is the question of "how this formula can work?"
How can NWBO say they have a formula that sells shares on Jun 20 and an input variable is the closing price on Jul 12?
Maybe free flux capacitors included?
The real question is if NWBO really did have those 2 dozen or so sales that were contractually priced based at least partially on closes on the enumerated late spoof days.
It is common to price offerings on the average close of the last several days. So it would be expected to see offering sales made based partially on closes from several days earlier.
But the claims list sales based on closes +/- 30 days. I am more than a bit skeptical that happened. This could be interesting.
If all is no problem, NWBO should be ready to submit any day. They knew the case would probably be dismissed and they would need to file this. And if all is on the up and up they already know the information and just need to assert it.
March 14 or earlier we have our first juicy news
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No, the MTD was granted but without prejudice. That means NWBO may file an amended complaint and we start again.
Odd, the paper you link to never mentions DCVax-L.