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So 3-4 years from its initial application. Now add personalization to the application complexity. The 1 year timeline by Aesop is BS.
Why don’t you look it up and provide the data? You’re the one claiming 1 year submission timelines, not me. Provide evidence. Also, don’t forget the fact that it’s personalized. Maybe you should look up that other dendritic vaccine while you’re at it and tell me how long Provenge took to get approved?
Again, you missed the point. Those applications are not for personalized vaccines. You are comparing apples to oranges.
According to whom does this application take a year? Can you direct me to the database that shows me how long an application for a personalized vaccine takes that is not being submitted by BP? This application is much more complicated than a standard biologic. Posters like you lie to tell us how long it’s been but offer no proof that it is in fact taking too long. Is 2 years too long to give birth? Yes if you’re human, not if you’re an elephant. Provide the board proof of your position. I find it ironic that your name is Aesop, a slave to his master who created stories.
Read my first post genius. I believe they will submit timely as well. Can’t keep track of my posts through your tears?
While you may be correct about debating timelines, the debate is actually if the dates provided in the PR are consistent. It’s been alleged that if you add up the projected timelines, then the projected submission date is wrong. That simply is not the case. The dates are consistent. Whether or not they adhere to the projected dates is another matter.
Stop crying about how long you’ve been here. This will be submitted timely.
I interpret the timeline differently. 2 weeks from the 30th would be 11/13. 2-3 weeks from then would either be 11/27 or 12/4. However, people generally work Monday through Friday so 2 weeks would be 10 business days. I expect the first part to be delivered no later than 11/10/23 (Friday). 2-3 weeks from that date would either be 11/24 or 12/1. You shave a a few days off in a best case scenario and the “between mid to late November” estimate makes complete sense. Also, it may not be obvious to some people, but the UK does not celebrate Thanksgiving. There is no holiday break that week.
I would have it disagree. It would take a huge dump by one warrant holder or a coordinated effort by multiple holders to dump on that one day. Why would they dump with application news around the corner? The most logical explanation is whoever dumped those shares that day knew a delay was coming. I believe it was the company itself that sold those shares knowing the price would drop once the delay news came out.
How do we know the warrant holders actually exercised their warrants? The increase in OS could have came directly from the company to raise capital. I would think that the 8 millionish share increase at the end of September was done by the company. They may have found out about the delay at that time and decided to raise at that price. That would have been the smart move by management.
I actually think they will do it this time. They’ve stated they will provide an update when the consultant has delivered the last section to the publisher. That’s definitely a change in communication. I also thought there wasn’t any way they would miss the last timeline so my track record isn’t the greatest.
I know how to read. Look at a calendar. Starting from October 30, there’s 5 weeks until the end of November.
Actually if they start the week of the 30th, 2 full weeks would be the 10th. 2-3 weeks from then 10th would be the 24th to the 1st of December. If the 1st part is delivered sooner, say the 8th, then 2 weeks would be the 22nd. That fits right into the timeline of mid to late November. Most people don’t say the last one third of the month.
Again with the reading comprehension. No I didn’t think it was random. It was obviously planned. Read my post again.
So they randomly issued a PR today and it wasn’t because everyone was expecting an update? Maybe you need help on your reading comprehension.
You must have missed the PR
Delays happen. I’m completely fine with the communication. Detailed reasons as to when and why. I would have preferred an actual submittal but we are not left in the dark.
The issue is not whether or not the application has or will be submitted; it is the communication to shareholders. Did they explicitly say they will PR submission? No, but it is implied. If they weren’t planning on PRing submission, then they should have adjusted the timeline by the 2 weeks needed for acceptance and stated they expected acceptance of their application in 45-60 days. If we don’t get a PR by Monday on this submittal, then management has done a poor job of communicating with shareholders and managing expectations.
After approval, not only will it cure GBM, it will get rid of cancers like you from this board. That’s tissue agnostic, right?
Shorts are taking advantage thinking the submittal will be late. Inventory of an available shares dropped by about 1,050,000 at 8am PST. This is why it’s important for NWBO to PR submittal this week. NWBO needs to control the narrative.
So you agree dendritic cell vaccine would be an approvable therapy?
Why wouldn’t they continue to run? Are there prostate cancer trials continuing to run with 97% survival?
It’s possible but more likely once you hit double digits. I think the minimum price is $7.50 but not 100% sure. It’s up to the exchange whether or not to offer options. If it hit $10, options for the month would probably be offered in .50 increments. Leaps generally are usually January of the next 3 calendar years. May not be 100% accurate.
By the time they get to their phase 3, this will be SOC with at least 60%+ survival. No effect.
I would have to disagree. I’ve been a shareholder for a little over 3 years. I’m not as jaded as the longer term holders. Missing this deadline gives management a bad look in my eyes. They could have easily guided 45-60 days instead of 30-45 days. I understand they used the word “approximately” but that would be no excuse to miss the 45 day window. At the very least, I expect an update this week. Either confirmation of submission or relatively specific reasons why they haven’t submitted and a revised date under 14 days.
Never know. Partnership news would probably get us there. I look at MAA submittal as the beginning to a lot of potential catalysts. Acceptance, Nature article, partnership, EDEN being accepted, applications to other RAs or some other other unknown catalyst could happen between now and the end of the year. We know MAA submittal is the first on the list. I have no idea the order of the other catalysts but pretty sure we will hit them all eventually.
I’m the dumb one, yet you cannot answer valid questions? It’s better you ignore me if you can’t handle the truth.
I wish people were as dumb as me. Apparently, people like you are dumber. Do the job descriptions say they’re hiring specifically for building 50? With a company as large as Merck, you somehow think only DCvax would require proteomics analysis and immunoassay experience from an employee? Care to explain why a floor dedicated to lyophilization has anything to do with DCVax?
People like you try to make these crazy connections that simply aren’t true. The company is moving forward. They will be fine. No need pump BS on here trying to raise expectations so the fudsters have more ammo when those things aren’t true.
It’s pretty clear to me Building 50 at Merck IS NOT related to DCVax. It’s likely for Proquad, their MMR vaccine.
The 2nd floor is for lyophilization, which has nothing to do with DCVax but is required for Proquad.
Just across an internal road from that building, Landis told the township commissioners on Feb. 16, will be “Building 50,” a new manufacturing facility that will be three stories tall and add about 101,000 square feet of space.
“There will be a three-floor setup: the first floor will be a loading dock, cold storage and mechanical. The second floor is where the actual production will take place,” Landis said.
“It’s a lyophilization area, which is freeze-drying – like Folger’s coffee – and then the clean room, and filling of vials, and then the third floor will be office area and mechanical,” he said.
https://www.pottsmerc.com/2021/03/02/merck-adding-manufacturing-space-before-vaccine-news/amp/
Yes, GBM would be an additional $3+ billion to that number. If they can use DCVax to somehow extend their patents, then DCvax becomes essential to Merck.
If Merck can use DCVax to open more indications for Keytruda, that should be good enough for Merck. The GBM market should be $3+ billion annually for Keytruda. If something like pancreatic cancer gets approval, that market is about 5 times bigger.
Why would Merck be involved in manufacturing, when NWBO previously had a contract with CRL who has much more experience in that area? Also, why would Merck spend that much money without having a deal in place? As much as I’d like you to be right, it just doesn’t make much business sense.
I agree with you. There needs to be some follow up news or we’ll get beaten down again. My understanding is that it could take up until May 2023 to get a response to this application assuming it’s filed this week. It’s been floated on here that an approval could come much sooner, but I don’t believe that would be earlier than late Q1 next year. There could be attempts to take down the stock right up until there’s a risk of approval coming out.
Combos are for treatment, not approvals. Having a hard time keeping your lies straight?
Should be DCVax-L alone. From my understanding, each approval needs to stand on its own.
I agree. This will just get beaten down again without some sort of follow up. I’m hoping it’s followed up by some partnership news.
Defending it is one thing but you claimed they let out a PR with the intent to raise money. Whether or not that can be proven, that is a securities law violation.
I think they’re smarter than that. Breaking securities laws to try and raise a few million dollars isn’t worth the trouble.
No communication next week would be a huge blunder by management. I have faith they won’t make that mistake.
We’ll hit over $1 before the end of next week
The Merck expansion cost about $400 million. I can’t imagine any company spending that kind of money without a deal in hand. I just don’t think the expansion has anything to do with us.