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They already did a comparability study for the Sawston facility (1 of the 5 workstreams). A Comparability study for Flaskworks should be a piece of cake. Here’s a little segment about what the EMEA says about it:
For the record, NWBO went from 22 to 25 employees in the last year per the 10k.
I agree basically w what you say which would be optimum but I don’t see BP giving top dollar just from drug approval. BP would have a hard time convincing their shareholders, who are not familiar w this paradigm shifting drug, of a justifiable partnership/buyout price. IMHO, NWBO would need to show BP and their shareholders/BOD that if they don’t pony up they’ll continue to go it alone till BP offers a buyout price or partnership in NWBOs ballpark. The United Kingdom is the training ground to show what DCVax-L is all about. The United Kingdom is that display window which will entice prospective buyers to step on in and check under the hood. That’s my view outside looking in which is akin to looking at the outside of a watch and trying to figure out how it works. Good luck w that and w what NWBO is thinking🙃. All IMHO.
BMS who bought them was the only known bidder.
Yep, Medarex was worth a lot more. It had a great pipeline but had a very weak CEO in Howard Pien and some other weak management types such as Chris Schade and Laura Choi. The company was based in NJ but Pien managed the company from California. Selling the company was perfect for his retirement but not for us investors.
NWBOs 25 employees gives me hope that they will go it alone for GBM in the United Kingdom. When I checked Linked In several weeks ago, I counted 16 employees but my Linked In search skills aren't that great and/or some employees didn't show up there. I was looking for signs they hired key personnel that would enable them to go it alone such as VPs/Directors of Medical, Quality, Regulatory Affairs, Manufacturing (they still need a presence here even if Advent is kind of doing the job), and perhaps Clinical, etc but didn't see them. Bottom line is when I saw the NWBO personnel on Linked In, NWBO didn't appear to be gearing up to go it alone but if some of those 9 additional employees are some of those key employees I noted then going alone may not be out of the Q. My belief is that NWBO needs to show they are serious about going alone to get the best deals possible w BP. Once BP sees that NWBO is serious about going it alone, it will be easier to get deals done for GBM or other indications in the United Kingdom and other regulatory jurisdictions. LP has already gone on record that for GBM they will go it alone for GBM.
Right! I found this person's posts humorous too to the point where reading the posts outweighed using the Iggy button, for now.
'pestilence19', that's a double entendre if you think about it i.e. Nemesis18 and Covid 19 🥴
There are so many jokes to be had from your political view both negative and positive but the bottom line is I don't think any politician wants to be associated or hint of any connection w you.
Pllleeasse, gimmie a break.
And already on ignore.
DCvax or not, it's good to read GBM success stories even if they're far and few inbetween.
I cited this section not realizing you posted it. Discovery and Beyond!
That was good weekend reading! I'm wondering if an oversees financial newspaper like FT has less to fear from the big bad wolf than one in America. Perhaps this will embolden an American newspaper to proceed w their own investigative reporting.
Good article. This can't hurt
The last paragraph gives a hint of what's to come!
Never mind
Well, I'm currently vacationing in Vermont. And I just got a photo w a cardboard cutout of him. Does that count, I asks facectiously. So close but so far away.
Impressive credentials!
Well, if you're going to tell me I have a short memory, I then should say, if you commented on why you posted what you quoted, it might have turned into long memory especially when you're trying to race thru all the posts. Otherwise, I hear you though. I've had several posts in the past where I barely got acknowledgement and others would post something very similar months later and get a crazy # of likes. So sorry about that.
Truthfan, in rereading The Vital Importance of Working in Partnership with Other Regulators – An Interview with MHRA’s CEO Dr. June Raine, I found the article even more interesting. My reason for going back to reread the article was because in initially reading it, I got the general sense that this well spoken person, Dr. June Raine, as CEO of the MHRA, is very much involved in communications w the other Regulatory Agencies. But heck, I didn't realize or let it sink-in initially that this article is posted on the FDA website and that the meeting in London was with a delegation of FDA senior leaders, including FDA Commissioner Dr. Robert M. Califf. One little item that caught my eye is she started her career w interest is in in drug safety and of course, DCVax-l has such a great safety profile. Here's another bit that caught my eye
Ha, ha. That made me laugh.
I check once in a while to see if they added any employees, and checked as recently as earlier this week, To the best of my Linked In abilities, they currently appear to have 16 employees. The Computer Validation manager is still there and they appear to have another manager different than the usual suspects but they they don't list what he/she does. TBC.
EDIT- I know they use periodic consultants to assist them in the heavy duty work such as putting an MAA together which I don't expect those consultants to be listed as an employee but am wondering about consultants they hire in lieu of a permanent employee such as a QA or Regulatory Director/Manager. Would they be listed as a NWBO employee? I got a 50:50 opinion on that.
Agreed, it's worth a read.
This has zero to do w my post. Try focusing on recent events. You know where possible problems can occur in the MAA review process and that's in the accuracy of the data and in the manufacturing process. With the recent Advent manufacturing inspections and MIA approval, we know manufacturing is solid. And I posted those PRs leading to and including data lock to show that the MAA review process won't have issues there either when the MHRA looks at the data. So when the MAA submission PR states
Totally agree that the 150-day process is highly likely, in fact, I think it's a certainty. DCVax-L is a new medicine for a serious unmet medical need and that's what the expediated review process is all about. ps It would be nice if they PR'd that info though.
The Dec 21 MAA submittal PR revisited. It's so solid in detail and information that I (really) enjoy reading it every once and a while. I'm reposting the PR and acknowledging much of the great info provided by red pencil and bolding that we know can be their own storylines (and were). And following that up w the 4 non topline PRs up to data lock which to me shows the MHRA won't run into any data issues during their review. The MIA PRs belong here too but I didn't post them.
Good article on OS; it's unofficially official, RAs want to see the OS endpoint for approval. In my linked post, I provided an example of 2 different drugs by 2 different biotechs hitting their primary PFS endpoint but the RAs wanted to see the OS endpoint before deciding on approval. In the article I post below, the RAs are not satisfied w the PFS endpoint to get accelerated approval unless there isn't another tool in the shed that would take care of it. They really want to see the OS endpoint. This article quotes Pazdar too.
Yeah, EU patent is a biggie!
Nicely said; this is a keeper.
Nice! Enjoy.
Nice! Enjoy.
Your point gives a half full glass point of view; 39% in target brings the glass three-quarters full.
Oh, please gimmie a break then you're #1 in that category.
I hope your right GB but NWBO PRing that they are further along in the process i.e. MAA has been validated, I don’t think puts pressure on the MHRA since it just shows they are moving along in the process. It just removes this little bit of doubt. For me, I would go from 95% certainty to 100%. Some, like yourself, have 100% certainty but for others it could be 50%. This stuff could be easily explained at Quarterly meetings but in lieu of that give some updates via PRs where everyone is not left to speculate. Anyhows, I’m just trying to explain why I don’t have a 100% certainty and why I wouldn’t be totally surprised for some unexpected delaying news to come out of left field. I am expecting good news in the Spring but for the life of me still don’t get why they don’t PR any good news in lieu of revenue news like other pre-rev biotechs. I am not used to that.
While that appears to show that the MAA is under active review, I say this w under 100% certainty. If a long-time believer has this problem, what is the average investor supposed to believe. As I’ve said many times, they should PR any positive info. When the PR was 1st submitted there was the argument by some including SOS that since the MAA was submitted it has been validated and/or they weren’t allowed to PR this type of info. Prior to that I argued any good news should be PR’d including validation. After SOS, I shut my mouth thinking to myself silly me. But after Stonkmaster got a response back from the MHRA that there is no such prohibition, that they could in fact PR positive info, that created doubt in my mind. Per Stonk
Well, let's see what the write-up is after approval.Hopefully, their attitude will have changed.
In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after ‘significant grassroots support’ Interesting, to say the least! Sometimes the FDA can be obstinate but it's a good sign they are showing flexability.