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Regardless of when these are published, the company is informed and will certainly PR it upon the actual decision date.
There is zero chance the first indication of a DC-L approval is on that site.,
Bad comparison.
As much as I often disagree with Flipper, on a 0-10 scale for posting "reality", he is at least 5 points above dstock.
The SPA is good news (did expect it, but sometimes can drag out),
Norse 8 is a non-inferiority study,. What that means is that they do not have to prove to be better than the ranibizumab, just as good as it. That is very reasonable from a common sense point, but has a tricky stat issue,
There is no such concept as "as good as" in clinical trial stats. Either one is better or not. But we all need the real world concept, so how to fix this?
The trial stat guys came up with a concept of a NI margin. Basically OTLK will be spotted a letter or 2 (do not know the details) and with that must prove to be better. This sounds a bit contorted, but there is no easy way to solve the conundrum
Now back to the FDA.. Obviously if the sponsor just says they want their drug to be spotted some advantage, the FDA may push back. And that is why getting the SPA for a NI trial really matters. The FDA has agreed that whatever NI margin is, is OK by them.
As far as executing the trial, That should be a given. There is ton of data here, we are not talking unknowns.
It will be interesting going forward to see when the proper generic name of murcidencel is used. And when it is not.
Maybe longs should demand corrections when it is not used.
Why should NWO shareholders care? The freezers belong to Advent, The freezers are the 2560 ft^2 of nitrogen cryostorage listed in the Adevnt sublease When equipment is part of leasehold improvements that makes it part of the facility. At least until 2037.
NWBO collects 125K/year on the Advent space. Now, the terms on that would get rational shareholders furious. But most here still believe the comical hype that Advent exists to support NWBO.
Is next news the 10K?
Likely. The usual suspects are suggesting NWBO is not going to say anything about the MAA status, so likely no news there. ASM is about out of math for happening prior to the 10-K.
So what might be in it?
. Eden milestones. So far only 1 of 4 has been paid. They are to be paid in stock so mandatory disclosures.
. The Advent MFG contracts. Why do they still pay $5M/year to manufacture at Kings when it is a fraction the capacity of Sawston?
. Revenue of course. The number itself ,matters little but why is it so low? It was way under even my estimates. Something is wrong there.
.
Other than that the usual mess of a balance sheet.
Oh, they probably have to disclose the BOD holdings (usually done in the ASM proxy but they forgot to have an ASM). Curious how they explain the disconnect on Malik's shares stated in him vs what NWBO states.
Why? You are correct Elios did not wait years for long term data on the early stage trials.
No bios do. Even NWBO launched the trial that became the P3 with very immature data in hand.
Actually, I do recall any any articles by AF attacking IMGN in the periods I was invested. I do recall one where he had SGEN ahead of IMGN. Hard to say that was a bash when it was clearly correct.
Oh, I forget. You did not own SGEN so you think they are worthless.
OK, yes it was Roach (obviously, as they own Herceptin)
But now you say IMGN went downhill because their pipeline failed. Before you blamed it on shorts?
One can debate what clinical failure led to the long winter. For me, the Marrianne failure of T-DM1 in first line was the decision to leave. That was a P3, the rest of the pipeline had a ways to go.
Comparing IMGN and NWBO is bogus.
IMGN had a broad a broad platform and partnerships all over the place, They had Kadcyla approved a decade ago (OK, BMY had it approved).
I have no clue what was going on with it in the 90's. I do know what was going on in the 2005-present period though. The price rose nicely on the Kadcyla approval, but then fell with the first trial trial failure as that left them losing money and no reasonable prospect for over a decade.
I was one of those who sold out back then. I saw no reason to leave cash tied up for that long. Only got back in when they actually were close to real results a couple years ago.
I see no reason why the ,market was supposed to support IMGN.
BTW, congrats on selling back in the 90s. I am sure had there been a message board then you would have been posting "strong buy" as you sold.
Hi Hoff.
Are you suggesting they made a mistake in the SAP where it says the 5th secondary endpoint is OS between the 233 vs the 99 randomized to placebo?
Page 15 of the SAP:
You are correct on one point.
LP has negotiated some very good contracts for herself when doing business with NWBO.
And she also does a good job of getting most all those shares for nothing. The 25% true up on employees options was a very good deal she negotiated. Same with bonus warrants for having the loan extended at a penalty interest rate. And let us not forget how well she negotiated to have those warrants not expire.
So LP negotiated great terms with LP and made a loan that anybody would have made.
10% for an on demand loan. The demand feature made the loan virtually 100% safe against both default and market risk.
Plus it included 50% warrant coverage with warrants that basically never expire.
Plus it included a convert option that was priced below market.
That as just so nice and caring of LP.
There s plenty of research with Poly-ICLC n GBM including DC vaccine combos.
https://jeccr.biomedcentral.com/articles/10.1186/s13046-021-02017-2
WTF is "the patent"? That is not a hard question to understand.
FWIW, I strongly suspect the negotiations over a combo CI trial have to do with getting a BP to pay for the -L being manufactured for the trial. Especially if the trial is in the UK.
Do you agree or disagree with my assertion that UCLA had their ATL-DC prior to NWBO (as did many others)?
We all know NWBO themselves have asserted they did. Or did you not know that?
I am not sure what exactly you are talking about.
I general patents describe what exists in the field, not just their own inventions.
I would be glad to either debate and/or admit I am wrong if you prove a patent number or link. But just saying it is "their patent application" is not very specific.,
Yeah, it is a bit iffy,
I assume you are looking at this link.
It looks like the CHM meetings tend to be published moderately regularly (within a few months). The others are sketchy. I am unsure if they sometimes update after the fact and that makes the dates look very late.
It will be published when it is published. And for once, not even I will blame LP if the update on that site is late
One more date on the calendar, though we do not you know when.
Sometime around late spring to early summer MHRA will publish the minuets of the March CHM meeting. They will note if -L is being discussed (they will not mention it by name, but a ATL-DC GBM treatment will be a solid clue).
Of course this could be made moot by NWBO PR'ing validation. But as of now it looks like DI is making clear that (a PR) ain't happening based on the story being spread through others.
Plenty of published results on their trials can be found here
It is definitely not DCvax-L despite being lysate based. And one of the 2 flavors does not even extract monocytes to grow DCs, it injects the lysate into the patient so it is recognized by DCs and other APC in vivo.
Two trial can be found on ct.gov. One of each type.
There core differentiator from the other numerous ATL-DCs is that they embed the lysate into a particle made of yeast cell wall material. Supposedly makes it tastier to the DCs.
They do extract the lysate via a freeze-thaw cycle, which I think was NWBO's core differentiator from the late 1990s.
No, I am suggesting LG left it in the pile of unpaid bills.
How much would it have cost NWBO to submit the declaration to the OTC a few years ago? About a few hundred bucks as it was all cookie cutter?