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22 days from MHRAapproval to FDA approval.Via what approval channel was this done?
In Europe, the Marketing Authorization Applications (MAAs) for exa-cel were submitted in December 2022 and validated by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2023. In the EU, exa-cel has been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the EMA, for both SCD and TDT. In the U.K., exa-cel has also been granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the MHRA.
Despite the drug’s clear benefits, Vertex may face a tough battle in marketing Casgevy, particularly in Europe. Biotechnology company Bluebird bio won an approval of a gene therapy for severe beta thalassemia in 2019, but two years later withdrew the treatment from the market after it failed to secure broad enough reimbursement of the $1.8 million medicine.
Yes, the posts where sh never said she heard of this acquisition, only that she believe it.
Just show the post by Senti and we can debate it.
Alas nobody else has seen it.
So you admit she never said anything more than she believes it.
Many people form opinions that they believe. That does not make them wrong for stating them as opinions/beliefs. But it does not make it evidence to support the assertion it is a fact.
You claim that Senti has said this as a fact told her by "deep throat" . And that she has provided details and dates.
Where did Senti ever post this? Come on Flip, you keep saying Senti posted it but somehow that post does not exist.
I could care less who you claim she heard it from.
Show me any post by Senti that backs your assertion she heard it at all, as opposed to being her opinion.
Come on, you said she listed dates and details. Where is the post?
If I missed a post by Senti saying she heard this from anybody then just point to it.
You won't of course,
I have never seen any post by Senti on this other than where she simply said she "believes it", It was in a reply to a post about what DI said, but she never said DI said anything to to imply it.
Again, if I missed a post, fine. Just tell me the friggen post. If not, I call total BS.
Probably money, but then, as “luck” would have it, the original publisher was apparently acquired by a larger more seasoned publisher.
Per an alert on my screen: Biden administration says it has power to seize drug patents to fight high drug prices. I wonder how that will work out…..patents that result from government funded research now owned by companies are involved apparently. But the government invented/discovered nothing, did it?
DD, here is another thing you might want to clarify with BARD. The distinction between a Broker and a Money Maker. Thus if I have an account with my broker, say TD, with whom I place an order to buy some shares in ABC company, and TD in turn places this order with say Market Maker Citadel and the order is executed. What happens if TD goes bankrupt, and what happens if Citadel goes bust. I believe that the Brokers are insured up to some limit should they go bust?
First, if a MM goes BK it is the DTC that gets stuck with the loss. The only way this dribbles back to brokers is if the DTC ($87 trillion in accounts) goes BK. And that would a 1929 level event.
Second, Bard is little more than a search engine on steroids. The net if filled with crazies on this subject, And that is Bard's world.
I love it.
You asked a general question about short shares in BK, and Bard just happened to reply with NWBO as an example.
Bard has learned how to feed you answers you want tot hear.
AI based click bait.
Clear for now this is a swing trade for him while the company is losing money, and he's got it all set up so that he gets to push the swing.
Have we heard anything about Edens of consequence in the last year?
I'm happy to say we feel that we've made considerable progress. Again, just to give you a flavor of it, we've tested multiple versions of the system. We've tested versions that had high rate, high flow perfusion of the culture and media. We've tested low flow or slow rate of perfusion. We've tested static cultures, all of which is to reach specifications about the yield of these products made through the automated system.
And because when we're ready, to ask for approval of this manufacturing system from regulators who are going to have to approve to their satisfaction that the product that comes out is fundamentally equivalent to the product that comes out from our manual manufacturing process today. So we've tested a number of versions of the system. We have a test system established at the Sawston facility. So there are teams working in tandem at Sawston and at Flaskworks facilities in Boston, and that is progressing.
During 2023, the Company anticipates that additional key areas of focus will include:
...
continued development of the Flaskworks system, including choice of the system version to take forward;
9 shares???
How is that even possible for NWBO to issue 9 shares?
Nobody is going to go to LP and ask for the company to sell the, 9 shares.
Options are in multiples of 100. C conversions are multiples of 25(?).
I guess the converts could have converted $10 (if that would even be allowed by the terms). But really? Probably costs over $100 in fees to do so.
This makes no sense at all, not that it matters.
EDIT: My best guess would be a data error was fixed.
You really haven't explained anything to clear this anomaly up.
What anomaly?
That DD thinks the number somehow reflects the short position? It does not.
It is the shares some particular prime broker has available for loan at any instant. That is all.
Seriously DD?
The number has been bouncing up and down in the same range ever since you go on this kick. What a surprise, it goes up and down based on market hours.
It does not mean that actual shares where shorted or bought. It is also that the various parties who are willing to lend shares change their position dynamically.
vator, the SEC form also said it was an A meaning Acquired. Did Navid sold and bought those exact number of shares at the exact price he sold?
Remember she said 2014? lol
In parallel with making DCVax(R)-Brain commercially available to patients at selected medical centers in Switzerland, NWBT is also conducting a Phase II pivotal trial in 141 patients in the US. The trial began enrolling patients in December 2006, and is anticipated to conclude around the end of 2008. The Company plans to seek product approval in both the US and EU in early 2009, based upon the results of the Phase II pivotal trial.
Northwest Biotherapeutics, Inc. CONTACT: Linda Powers of Northwest Biotherapeutics, Inc., +1-240-441-6047,+1-240-497-4060
They’re bunch of incompetent folks.
IMO - if NICE does complete a review of Multikine and they say it belongs in the Great Britain SOC for head and neck cancer,...
Or maybe Flip is just getting tired of the crap this message board is degenerating into and sees this as an exit plan from the board.
If MAA submission is after the New Year starts, I won’t be posting here anymore. I will reserve one post for 2024, although it does not comply with the bet, to provide a look back.
Submission. You just stated the other day you are 100% certain of no submission in '23 yet you appear to have no confidence in your own statements.
Going to miss correcting your daily vomit of false information after the winner of our bet is decided.
LMAO.
Hoffman is an idiot. That Sawston has an export license means the UK will allow the product to be shipped. It does not mean any country must allow it to be imported and used.
If anybody thinks the UK can decide what drugs can be used in the US via an export license from the UK they are whacko.
Nah. Les owns millions of shares. May be you are talking about common shares.
Consists of 172,742 shares of common stock held by Mr. Goldman. Mr. Goldman also holds 643,043 warrants acquired in past years, as previously reported, from the Company in connection with loans by Mr. Goldman to the Company when such loans were needed to help the Company to survive. Mr. Goldman holds 24,500,000 options awarded in 2018 for service during part of that year and a number of preceding years, and 34,449,394 options awarded in 2020 for service during the rest of 2018 as well as 2019 and 2020.
Didn’t Les transfer his shares to a trust?
You would do better to use the actual numbers reported to the SEC instead of stock twits quoting sites that mechanically scrape Edgar and are often wrong.
LG does have only 170K common. But he does have about 58M employee options. Per the latest ASM proxy. The other numbers listed in the twit include options.
The number for N Malik is also way wrong.
SEC Edgar vs Stock Twits. who to believe?
Ownership by BOD is reported by the company in the annual proxies. It is reported independently by the Director via form 4.
Both of these agree.
He purchased 10,000 shares at $0.001 share in 2012,13. Good for him, he was only a couple years late in reporting that (was that triggered by the SEC letter to NWBO for failing to report beneficial ownership by LP/Cognate).
Then on on 5.28/18 he was awarded 9,065,000 stock options for being on the BOD. He actually reported that on time.
The NWBO reports agree. They assert he had 10K for a few years, the 9,075,000 until last report.
I am just accusing Malik of sloppy reporting. Being late and failing to report option exercises. Neither enough to get more than a yawn out of the SEC. But concealing 10+ million shares (and possibly at a time when that was a large percent of the company) as you suggest would be fairly serious.
BTW, the recent form 4 did not say he sold all his common. He still has 740K of common and nobody knows how many options.
1. It's the responsibility of the insider themselves to file a form 4.
2. You can get an extension up to a few months to file a Form 4. An example Bard gave is when cashing out warrants and/or options. It appears this might have been what Malik did here.
Which is still no more than an accounting entry for the shorts (delivered or not). Zero cost.
The idea of a dividend, split, uplist or downlist to screw shorts is comical. Just like the billions of shares of naked shorts asserted by the bran trust.
Flipper: I don’t get paid or asked to post here
Danish Dude:
I was, of course.
Speaking of the PIM designation.
The purpose of that is so that when companies complete a P3 they can quickly submit the evidence (without all the detail of an MAA) and get a temporary approval via the UK EAMS program while waiting on the full MAA process. Would have had -L on the market 2-1/2 years ago.
Crickets on that.,
Wonder why?
It (6 digit trades) is no more than people who have the access to them using it to line jump the bid/ask for pennies (or fractions thereof).
That it is unfair some can do this while most retail cannot is a fair statement. That it really matters much for overall trading is nonsense.
Did you read what she posted????
It never recalls any conversation or even states one even happened. It is her opinion of what happened with the submission.
The thing to "get right the first time" was the trial.
The submission? That can always be changed. Sure, it resets the clock to some extent, but taking years to submit is no better.
The trial design? No, that cannot be done over w/o anew trial (no matter how much NWBO fangirls want to think it can).
A decade ago when they restarted the trial they knew the design had warts. The psPD issue was well known and the implications for immunos was sufficent enough to change the criterion for evaluation of progression. They also knew by then the only approved DC vaccine had filed a trial with progression as the primary (despite OS being "stat sig") and had tp wait for a P3 based on OS to get approved.
But then LG gloated about how they saved time and money by relaunching with the old protocol.
That was the time to get it right.
Senti shared what appeared to be an accurate recollection of what was shared to her by someone (one would surmise the PR Dept) regarding the publisher having been acquired by a larger publisher some months back,
How do we know that a larger publisher came and took over?
The endpoint of OS for 232 vs 99 is still a secondary endpoint of the trial and certainly has meaning. One would expect that if -L works then the 232 live (numerically) longer than the 99 despite the crossover.
Of course the 232 vs 32 means nothing.
OS in early stage cancer is almost always a confounded by subsequent treatment (often including the investigational drug tself as often already approved in later lines). This is just something that trials live with. Nobody keeps pointing out how often all those CI front line trials fail OS with placebo patients using the CI post progression.
There is no reason not to publish the endpoint just because it is confounded.
Further, it would hugely positive. if even close to stat sig. Why would they not be shouting t out?
On the LTFU issue, you still have issues. Despite what you and flipper assert, finding censors does not have to lower the OS. It could go either way depending on how long the lived after the censor. If the censors were unbiased and random they would have no effect. True, there likely is some bias. But you still are talking a fairly minor effect from the few found LTFUs. More on the numbers on a post later.
Who currently has ownership of those original 16 suites I don’t know. Could Cognate end up similar to Advent with NWBO owning the equipment……. possibly
1. Cognate did not fleece, and they are still a unique resource for NWBO.
2. Correct, Cognate and Advent are not NWBO, but they are unique resources for commercial cell manufacturing that NWBO does/may use for making its DCVax platform products.
.3. The FDA accepts ECA trials along side other confirmatory data.
4. Admittedly, imo, NWBO and the NIH should have poured far more resources into Flaskworks earlier on, but their manufacturing, intellectual property and validation progress is undeniable.