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Here are some scenarios.
Here are some scenarios. pic.twitter.com/P1Ucr4b2Tz
— Woj (@wojciechduczmal) September 3, 2023
Thanks, that's very helpful. I still can't find the bit about the CHM meeting being the starting pistol for the 150 days.
Hi Flipper,
I could do with a sanity check here. I've dived into the MHRA approval metrics and here’s what I’ve found. Although there is no audit of the new Accelerated Approval pathway, I found a slide that would normally apply to us on page 9.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1163710/MHRA-Performance-metrics_2301-2305.pdf
That is the median time to determination (approval) from validation (submission accepted) for New Active Substances (NAS). As you can see from the graph on page 9 that in March 2023 it was 210 Days, there were no approvals in April, and in May the median was over four hundred days.
The accelerated approval runs in two phases. The first phase is a maximum of 80 days at which point the MHRA issues a Request for Information (RFI). The 150 day clock is stopped and the company has a maximum of 60 days to respond. Phase 2 starts after the company responds and runs for a maximum of 70 days. If the company requires more time than the allowed 60 days they have to negotiate it.
Here are some scenarios. Given the potential of the treatment and the novel way it is produced, it stands to reason that the application is likely to attract maximum scrutiny (ie the full time allowed). I consider it unrealistic that the MHRA will take less time than stated. I don’t believe they will rush this through. Why would they? It’s already an expedited process.
Here are some scenarios. pic.twitter.com/P1Ucr4b2Tz
— Woj (@wojciechduczmal) September 3, 2023
The original post referred to an application to the UK's MHRA. Their office was closed on Monday due to the bank holiday.
Monday was a bank holiday. A day off. So perhaps yesterday. BIO99 on twitter noticed that there was a spike in google searches for 'Murcidencel' this morning. Went from zero to 100 searches today. The spike we got around Topline was 30 searches for 'Murcidencel'. My hopeful guess is that a PR package has been submitted to journalists today under a 24hr embargo to lift tomorrow and they've begun writing their articles...hence the spike in searches. Might explain the 15% spike. One of these days, lads!
linda.geddes@guardian.co.uk
I remember being sceptical back in the summer of 2020 when David would repeatedly state that they would PR Data Lock...which they eventually did. With that logic, I have no reason to doubt that they will PR the submission.
I think you need some kind of an Adobe upgrade to open a million page PDF.
Didn’t they tell us at the 2020 ASM that they wanted to announce data lock but because of
Covid they had to delay?
Thank you, Luther.
Wow! Seriously? Could you share a link? Huge if true.
I was also confused by that number. I would've thought it was closer to the total number of shares that were sold by the company in 'the relevant period'. We went from an outstanding share count of around 350m in early 2017 to 1.05b in the period in question.
Sorry, Flipper. I think that was added by the stocktwits poster.
Thermo's post is number 536148
I appreciate how unsentimental this message is. You're right. It's out of our hands, but I hope the full narrative will finally, at some point make sense. It's also worth pointing out that in all the years of speculation on this board, and all the alleged 'expertise' present, there's not a single mention of 'spoofing' or any other theory that was remotely close to what the lawsuit alleges.
Thanks. I wonder if he knows anything about that £375m that was announced for urgent, innovative, pre-approval therapies. I always thought Sajid Javid was talking about us.
Do you mean the email you received back from your MP had that subject line?
Just one more question before you go! Will it be a white Christmas? By that I mean will I be able to afford cocaine this Christmas?
I wonder if they’re being cagey about confirming letting go of Powerscourt because you could reasonably claim negligence for not having a PR strategy or resources lined up for the most important event in company history.
Utterly insane. Five weeks til the end of the year and possible commercialisation. No CFO. No COO. No PR agency to push ‘…astonishing results…’ in a ‘medical breakthrough’.
Flip, did you see the OS @ 50% slide making the rounds?
Thoughts?
I don’t really believe in coincidences. I’ve heard of them, just never seen one.
Some credit should go to Flipper who was the first one to point out that the Seagen play was good Poker by Merck.
…and on August 26th we found out that Merck had lost interest in purchasing Seagen.
JAMA is the most widely circulated general medical journal in the world, with more than 290,000 recipients of the print journal, more than 1.6 million recipients of electronic tables of contents and alerts, and over 38 million annual visits to the journal's website. JAMA'S reach includes a growing social media presence (more than 982,000 followers on Twitter and Facebook) and vast international news media exposure.
Frequency of Publication and Access.
JAMA is published 48 times per year in print/online issues, and new articles are published every weekday online. Without any author fees, all research articles are made free access online 6 months after publication on the JAMA website. In addition, the online version is freely available or nearly so to institutions in low- and middle-income countries through the World Health Organization's HINARI program.
"Confidential" deal! Is this the first time Keytruda's been allowed on the NHS?
Is this 27% rise outside of what the rest of the sector is doing?
I saw 'Duplicity' a few nights ago. Highly recommended. It's a romantic comedy about corporate espionage between rival pharmaceutical companies. The macguffin of the piece is a secret formula for a shampoo that re-grows hair. A cure for baldness.
Just wondering if there's been a 'mood leak' at Merck & Co.
See my post to flipper for an alternate theory.
I agree it was a BS excuse, but I think there was a glimpse of what they're actually up to in the refusal to update the US endpoints.
I remember there was an air of resentment when David was later discussing the EU change. I sensed genuine surprise and irritation that the Europeans 'leaked it'. The resulting run up in price was unexpected and unwelcome by the company because they had decided by that point (September 2020) to go quiet until they were further along in manufacturing and regulatory matters.
Here is my speculation about those months.
With all sincerity, they announce data lock in August and promise TLD in September.
Some unknown catalyst causes them to decide on the strategy we are still living with today. They seemed to have turned on a dime, so I think this is an outside party introducing some new element. No way the SAB and BOD just change their minds at the very last moment, especially after the COVID delay. This came from outside and at the eleventh hour.
They prepare for some egg-on-face and write the infamous Oct 5th U-turn PR announcing the quiet period and Journal route. But wait...in the meantime, quite unexpectedly, the EU updates the endpoints and creates demand for the stock that sails it to $2.50.
With me so far...?
It might be that they already had a handshake, first refusal, favoured nations deal in place with a buyer, and in that would've been a gentleman's agreement that the company not do anything to hype itself and inflate the share price. Changing the endpoints on the FDA site would've added fuel to the fire, and I believe they needed to be left alone at that point. Hence the slightly panicked resentment I detected in their tone almost two years ago. The run up in price was a risk to the deal. That's why the company didn't welcome it, and that's why they've been downright obstinate in updating the FDA (despite begging them to do so by some on this board). This is too wilful an act to be mean nothing. They've had to repeatedly justify their lack of action and still chose not to amend the 'error'. So that means it wasn't an error.
The cat was out of the bag on May 10th, so that's when the US was updated (when it would no longer look like a preview event for good news, ie. hype).
Just my two dollars and fifty cents worth...
I remember someone sharing their conversation with DI about this. The gist of the answer was something like “we would be accused of market manipulation if we were to update the US site.”
I would've thought the SAP acted as the common reference between the Company and the FDA. By not outright rejecting it within thirty days the agency signalled its approval. Unlike in the EU which updated the clinical trials register to reflect the new endpoints (which by definition would require the use of external control arms).
No. You're cherry picking across two of my posts which do not contradict one another.
My argument was that IF there were informal talks two years ago, it then makes sense for the company to have gone dark.
I disagreed strongly with your idea that NWBO would work in step, in tandem, and in secret, with a Buyer in order to walk the price up to a more palatable buyout level (so their shareholders don't riot). I think that would technically count as conspiracy to commit securities fraud.
Your 'rioting Merck shareholders' thesis presumes laziness and stupidity and capriciousness on the part of Merck's current shareholders. I don't agree.
We'll see soon enough.
I see the logic and prudence behind your argument, but I disagree that the current share price dictates the maximum amount someone might pay for the company. We are in a place where the share price is entirely divorced from the value of the company.
There was a news story a few years ago about a piano tuner who discovered half a million pounds worth of gold coins hidden underneath the keys. The piano had been purchased for a few hundred quid. Would you say that - having discovered the treasure - no one would pay more that £100k (the price of a new Concert Grand) because it was recently a bargain?
An enterprise is worth whatever anyone is willing to pay for it, and I believe we are hugely and artificially undervalued already (my guess is by a factor of 10). There is zero chance that NWBO or any of their potential suitors haven't done the math on what the company's potential worth is. Projected revenue times some multiple. Current share price is irrelevant to those negotiations...brutal as they might be.
If The Buyer was worried about the optics of paying some ungodly multiple of an OTC share price, and wanted to 'work with the company' to raise the price, they could have started this process two years ago without falling foul of any embargo. I find it hard to imagine how such an informal arrangement could be reached, or why NWBO would agree to it, seeing as they could finance operations themselves and avoid being tied to a single suitor for the most vulnerable part of the process (Data Lock to Approval and Manufacturing at Scale). I wouldn't want some Swiss giant breathing down my neck for this part.
The market is making a mistake in its pricing of these shares. This will not influence the price paid in a buyout, should it occur.
I'm gonna go out on a limb and say KIPK's wonderfully relentless posts about a '25B-50B valuation coming' is spot on. BP offered 25, Linda countered with 50. We'll see where we end up.
I had a similar thought recently. If we were to be purchased at a premium, the Buyer might want to keep all the media powder dry and have their name - rather than NWBO's - associated with the DCVax breakthrough.
What I don't understand is how a binding agreement can exist between The Journal and The Company. Is it normal to have the trial sponsor embargoed? I understand an embargo against publishing details of the scientific article[/I] under review, but the results themselves? It only makes sense if this is a strategic (artificial) delay in order to move 'all at once'.
I'm hugely excited for the near future, but I no longer buy the idea that 'the results and trial were so complicated' that it needed a peer review (which was the standard narrative here over the past two years). The May 10th presentation was unambiguous.
Something happened almost exactly two years ago...in between announcing in August 2020 that data will be revealed in September of that year, and Oct 5 2020 which ushered in this unprecedented twenty four month delay in 'official' TLD.
Can anyone jog my memory as to the dilution over the past two years? My instinct is that it was all the exercising of previously held warrants, rather than offerings, but I may be wrong. If there were informal M&A talks two years ago, it would've made sense for the company to go dark and begin to dot the i's and cross the t's, knowing it could finance operations quietly with warrants that would be exercised anyway.
My final thought about why a buyout is on the cards is the fact that this company - who will be ready and approved for commercial manufacturing in the UK by the end of the year - still has not hired the dozens and dozens of marketing and finance and logistics people necessary for such an enterprise. They are still acting as if they won't exist in January (in a good way). Would love to hear some counterarguments to this.
If we get an ASM proxy and there is no shelf increase then we've been bought, surely.
Thank you, Bio. Much appreciated.
The Annals of Oncology website is still showing the 'current' issue as the 'August issue'. This is the first time since I started looking in January that a previous month has bled into the current month. The last four issues were published a week before the start of the month. Probably nothing, but maybe something.
Senti, have you any sense why, despite all the subtle and positive signals from the company since May 10th, we haven’t seen a buy in from a big fish? It’s hard to imagine that no one of consequence has connected the dots. We had that run up in the autumn of 2020 and then a spike ahead of the May presentation and then…nothing.
Are we that below the radar and anonymous? Are the likes of Credit Suisse no longer interested/weary/risk averse?
I’m entirely certain of the outcome but profoundly confused at the market response. Haalp!
I would like to add to your point by suggesting that any company that incorporates the word 'cure' into their name without substantiation is to be treated with suspicion.
How dare they.
Imagine yourself to be a newly diagnosed patient, and your doctor says "There is this new treatment available from a company called NovoCure." Wouldn't your ears prick up at that?
It's beyond cynical. Marketing-led arrogance masquerading as science. I haven't the wit or data to dismiss it outright but it's always smelled bad to me.
Pictures of happy bald people, peaceful as Hindu cows, wearing hats over their $21,000 per month devices on their heads. Not good.
Thank you, Flipper. To your mind, does this mean the 80 Day clock starts ticking once we hear of the application being accepted? My view is that they won't PR (and therefore we won't hear about), submission, but that they will PR the acceptance.
The NYAS presentation stated clearly that the enrollment halt was for financial reasons. It's page seven of the DCVAX.pdf.
I imagine you're now pathologically allergic to any kind of speculation, but I wondered your thoughts on this:
It sounds like the company will be in a position to announce the acceptance of the MHRA application around the same time that this class-C financing might be ready to talk about (ie. before the Journal Article comes out).
My question is if you think that might be enough to ignite a wider interest? Would it depend on who the partners are? Is a PR on the Bloomberg stating 'MHRA Accepts, Big Fish Takes a Stake' the kind of thing people in your profession notice?
This is my sixth August with this company and I learned to save my pennies for the inevitable lows during this month of holiday. Would they risk such news dropping when no one is paying attention? It is silly season after all.