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Yes, unfortunately.
Shows clearly the sad state of affairs QTMM is in.
Why are we arguing about whether or not we'll get a PR for acceptance?
DI is our PR representative. Shouldn't his say be what we go by?
Fair enough. We'll see what the next couple of months bring.
1.) The Quarterly report ending in June 30th stated the following:
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823001633/nwbo-20230630x10q.htm
Page 26:
Let's hope it works out
Not the full docket, though here is the order of the court recommending MTD to be granted.
Caveat is the court is allowing plaintiffs leave to replead.
https://twitter.com/brogan_marcus/status/1740829422532604172?t=yLuLOSxOJf9RnFPdSvraDg&s=19
Court recommending MTD had a bigger impact to the share price than MAA submittal.
F*cking bonkers.
From NWBO 's Press Release:
We've fallen into this before, where we are overly optimistic and eventually came up short.
My expectation is May/June. If it happens quicker, all the better.
Very odd that the PPS would continue to slide down after an MAA submission.
I believe anticipation of PH3 results
That wouldn't make sense.
We do not have the manufacturing capacity for all 3 regulators to sign off on that. We would need CRL to come into play and/or Flaskworks (along with inspections) before pursuing regulators outside of MHRA.
Surprising that Karuna’s PPS deflated during the time period between submission and acceptance.
Interesting that 3 weeks after acceptance, major news hit. Hopefully we get similar news.
Folks remember:
We still need acceptance, followed by approval. The company also expects the MHRA to submit an RFI (per their PR).
I’m confident we’ll achieve acceptance and approval with no issues, but I just want to keep our expectations level. Don’t want us to expect a <90 day approval turnaround and it doesn’t happen.
Obviously it goes without saying that I’ll be excited if we do.
There may be a Request for Information (RFI) during the MAA review process. The MAA process may also take longer than we expect hope due to the following:
Would have been higher without the delays, but at least we have submission.
Need acceptance to fully get this train going.
At the minimum, they would need Charles River Laboratories. Makes things logistically easier in the states.
Although I don't know if CRL would need an inspection like Advent went through for submission.
Don't you get my hopes up 😅
There is no guarantee that the "Fudders" will hold their side of the bet. This board will divulge into a cesspool of sh*t with the current bet.
Perhaps, but you never know with NWBO’s recent track record on the MAA.
I sure hope it’s not, because this would mean the publisher would have to receive this supporting documentation, and THEN review the MAA as a whole, which could take “several weeks” per the last PR.
We will be looking for a submission by Mid January or later.
I see, understood.
I assume we won't have export license until we get approval outside of the UK?
This is dated September 8th. This appears to be old news.
Disappointing, to say the least.
I HIGHLY doubt the majority of those betting against a 2023 submittal would keep their word and stop posting.
Last week before Christmas. Hoping submission occurs prior to the holidays.
Had a dream last night that they submitted today and the PPS exploded. Let's see if I have the ability to tell the future :)
Doubt those who FUD against NWBO will keep their word and leave the board if we submit before then.
They have placed too much energy into this board to do so.
The one we are waiting on is the combo trail correct?
NWBO is in the latest Nature Journal.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173415851
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 13, 2023
Therapeutic cancer vaccines: advancements, challenges, and prospect
13 December 2023
"These results from the phase 3 clinical trial offer a newfound sense of hope for the treatment of patients with glioblastoma"
In a recent phase 3 clinical… pic.twitter.com/vuO6L6l4Jt
No. FDA will be at a later date.
UK MHRA submission should occur anytime between now and late January.
Why would NWBO go to a small publisher with something as Pivotal as DCVax-L?
Wonderful start.
I think the official close is mid 2024 for IMGN. If there are illegal shorts I would suspect a squeeze between then while they cover.
But not entirely sure how that works.
Good to see the PPS rebounding. Shows investors are still positive with what’s in store.
Let’s see what the next few weeks will bring.
lol he actually called it right.
We have risen in PPS several times in the last 3 months. Thus far, each time we were met with less than stellar news.
I suspect it’s anticipation for December news, not anything substantial.
How do we know that a larger publisher came and took over? I saw the talk about it, but what I gathered was that it was more of a theory than fact.
I would be interested to see how different the articles are written compared to each other. The WSJ is mostly blocked by a paywall.
Thanks Mike, I believe that was several months ago before NWBO sent their respective PR's about the MAA status.