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The NICE (non) response to Q1 is as one would expect. NICE will not comment on MAA's in process so cannot very well say how a submission effects them. All I have ever heard from them is that they try to align with a possible approval date.
The second question did provide an update. Specifically the scoping is still in the future. That step that is prior to the meeting invite, which is when their clock starts. It had been asserted in the past by hoffy, about a year ago, that they were already past that as they had a scope from 2017.
Still liasing with NWBO while coach Dean Smith cheers on the the slow play by LP and friends..
Is it not off topic to suggest bringing transparency on this message board?
Or is it just an oxymoron, like non annual ASM?
You have a serious failure to grasp the core issues here,.
One can argue DNDN had more block buster potential. But even after approval is was a fiscal nightmare. The cash bleed was heavy and the debt was huge. They had no legit plans to improve the situation, just hand waiving on "automation" and "EU" . The BK for DNDN was easy to see as far back as about early 2012.
AMRN may no longer have huge potential (barring some serious turn of events), but is is not far from being a modestly profitable company with a very sound balance sheet,
In your posts you totally confuse valuation and risk of BKK..
I am a skeptic when people talk of PPS of $15+/share. But for those who call for BK in this decade I call total BS.,
Nope.
I offered a bet on approval of the MAA with terms of double or nothing on the sig line.
I frequently corrected Hoffmans lie about the bet, including as late as mid Dec despite by then thinking the odds were fairly good they would miss.
Flipper, you might take a closer look at the clinicaltrials.gov site.
First, it clearly is some form of ATL-DC (nott starting a debate on the question of it being -L or not). The description is
What is complicated?
The FTD numbers you post are the cumulative number of fails to deliver. They are most all "naked shorts".
But the number always goes to 0 several days later. That means they were all delivered by then.
Yes, naked short selling exists. And illegal short selling selling exists. The numbers are trivial though (for NWBO and MMTLP), and the data you post supports that.
They spike 3 days after high volume days.
Notice they also go back to 0. So it means they were delivered late by a few days is all.
It is more than this.
The Judge tossed NWBO's theory of long term price impairment. That reduces the scope of the case significantly.
NWBO will now have to show a clear establishment of why the sale prices of the 30 transaction (11M shares) was based at least partially on the EOD close of the spoofs that were late in the day. Will be interesting to see the next refiled complaint, could be a while though (it is not due in 2 weeks and somebody asserted).
Anybody wonder how it is that these attacks on NWBO happen when NWBO is selling stock? Who benefits if the PPS drops on the day that established the NWBO sell price?
Certainly some similarities between PPHM and NWBO, but also some significant differences.
Both basically one drug companies. Both claimed their drug would work in all tumors. Both only advanced a single indication. Both had unexplained issues with their trials. Both claimed success in failed trials. Both spend heavy cash on building CDMOs.
Two large differences though.
PPHM owned the CDMO they built. At the end of the day that made many longs whole or better. NWBO will collect about $130K/year in rent from Advent is all though.
The other is management. Both had some deadwood on the BOD, but that is life and just a marginal cost. The real difference is King vs LP. King just did not have the experience and ability to make PPHM (nor CDMO) a success. While LP has this, but looks to more interested in the related companies that she has more ownership interest in.
NWBO longs have often asserted that the past failures do not matter.
One should trust the story presented by LP et all despite decades of lies.
Thanks, I understand that issue.
It would be nice if there was an easy way to post docs such as that.
Then why not just post the report? It is public information.
In fairness to LP, it looks like she sold off some potential profits from the suit for a few million dollars. The suit is on contingency, so not that expensive.
LP is not dumb,.
Discovery goes both ways. So some NWBO resources will be taken up. But so what if LG has to spend a few weeks in front of a camera disclosing shit. All that does is conflict with his time on the Big Booze Show,.
Thanks.
So basically NWBO will file an amended complaint, Then Citadel et all will file a new MTD. So maybe summer 2024 at best to have a ruling on that.
If the Judge says that is a go, then starts the discovery dance which can easily take well over a year (see Harrington for a good example).
Clearly no trial in 2024, and unlikely n 2025.
Thanks RRH.
FYI, the document is not copy protected, so you can post it. My PACER account is temp. locked so can not get it myself right now.
Mitigate is a total non-issue.
By the letter of the law, Kaiser is responsible for submitting results within 12 months of trial completion. And that would be now.
But be real. It was all hands on deck for Covid when this started. And now it is "who cares", The FDA is very loose in enforcement on this regulation, and I seriously doubt they would care in a case like this one. Maybe if AMRN was trying to hype Vascepa for Covid the FDA would demand the data, but nobody is pushing it.
What she has been doing for years.
Keep NWBO afloat by carefully playing the news while using shares to bring in cash of which much runs to LP and friends
What exactly is the point of pointing out the minuscule institutional ownership?
0.3% of shares.
A dollar value of under $3M
Was not deleted by me. I assume it was by the normal mod./admin deletion process that decided it was off topic. If you actually have access to deleted posts, it would likely be 11/22/2022 or a few weeks later. Should not be that many posts to check.
Anyway, with the current set of rules most mod activity is pointless. Once attacks against posters was allowed it is basically anything goes.
Hoff, at least you finally found the right graph from 2023. page 11, figure 6 Now try reading it a bit better,
The solid blue line is number of approvals in the month, the scale is on the right. So 7 MHRA approvals for the year,
The median approval time for those are the solid red bars measured against the scale on the left.. They are all over 350 days.
You want to pick the rolling median, but that has a problem., On months where there were no approvals it drops to 0. Kind of makes that number pointless. If you look at the graphs with plenty of data you see the dashed lines are what one expect, a rolling average of the red bars. But because of the 0's being averaged in it fails.
But f you think the MHRA often having an approval time of 0 days is real, go for it.
That was before even my time.
Of course LP has a plan, and the "shorts" do know it.
What "longs" fail to grasp is that her plan is not what aligns with your hopes.
The only news that will really matter is:
. Approval
. Partnership (and that does not mean a combo trial).
Have fun watching the market reaction to non-news like MHRA acceptance, NWBO hype of combo trials and Advent.
I like Flippers date for Aug 24, 2024.