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So Ex, why should the HTA inspection for, w subsequent license granted to, Advent Bioservices by the HTA (Human Tissue Authority) for "Storage of Relevant Material", "Distribution", and "Storage" be about manufacturing? Another inspection for commercial manufacturing, w subsequent license granted, to Advent Bioservices, by the MHRA this time for commercial manufacturing was given in March of 2023.
Why Are Prominent Candidates Declining Job Interviews With the Red Sox? I didn't read the article behind a pay wall but I laughed when I read the headline. Us NWBO ihubers know the reason right? John Henry owns both the Red Sox and Stat News. These potential job candidates are smart!
Yes, I believe it does. From reading the literature, it seems the CHM needs a certain amount of time to do their assessment.
Altnsider, your DD is making a lot of sense. I could envision they had buy-in for the MAA as is and then another agency threw a monkey wrench into the application demanding more detail of one sort or another causing this recent delay. You know I’m skeptical about a lot of this stuff that people say happened that hasn't been PR'd like rolling review or submitting the application awhile ago (at least this ship has sailed) but for Project Orbis it would probably be part of a MAA submission PR.
And the best part about the possibility of Project Orbis is it would dovetail nicely w my theory that Sawston will be the global manufacturing center. I just gotta think comparability studies on frozen leukapheresis material is a done deal. If Flaskworks is 10 times as efficient as manual processing then Sawston will be able to process 120,000 patients per year.
Comparability studies + Flaskworks = Sawston worldwide production
The "new" CHM meeting for the submitted application will almost certainly be on March 21-22, 2024 as opposed to the previously expected date of January 25-26, 2024 (w the previous wishful thinking CHM date of Dec 21-22 based on a submission by Sept 25th). The new CHM timeline is based on a corresponding submission date by Dec 25th. The "new" wishful thinking drop dead date for submission is Nov 27th w corresponding CHM meeting Feb 22 - 23, 2024.
Now unlike the last PR where we were closing our eyes and crossing our fingers hoping for a Sept 25 submission PR, we’ll have better certainty if we’ll be able to meet the wishful thinking, punchers chance (wearing brass knuckles) submission deadline of Nov 27th. We know that because the PR states
Yeah, I don't anybody is thinking they'll apply to all RAs simultaneously. It's a MHRA MAA PR we will get w subsequent RA submission PRs and venti lattes to follow.
I hope it would have to do w EDEN; they were still optimizing it last Dec, or 10 months ago. Is that time enough? I also have mused previously that perhaps it had to do w removing temo in treatment. I doubt that (it was a musing) but who knows. Your gut, my gut, et al tells us it has to be something, otherwise, it would seem inexplicable.
Yeah, jumping out of the frying pan into the fire. I've seen that happen w Medarex. Made lots of money w them but it could have been much much more.
That's the spirit!
Other biotechs PR the beginning of the rolling review process, as well as completion of the rolling review process /acceptance per my examples this summer (eg Vertex, Adaptimmune, Madrigal). So I would be expecting the same from NWBO. As I said, I'll believe it when I see it.
Now that's taking the bull by the horns. Reminds me of Dr. Salk testing his experimental killed-virus vaccine on himself and family,
My point was, and still is, we will know when they submit via a PR....just like every other friggin biotech that I checked does.
Did today's PR change your mind.
Hopefully, we'l find out soon enough. Let's revisit this once their is certainty.
ILT, NWBO is similar to most pre-revenue public biotechs in that they can be slapped around silly till their success as an ongoing entity is assured.
YES, there is a reason. It confirms what they anticipate to be probable is true. It becomes true and not probable. And damn, it's just good PRing practice. Many, like me, won't believe it till we see it. All other public biotechs that I checked PR this stuff. No reason not to PR it. Absolutely none. If they didn't PR by Monday morning, it didn't happen within that 45 day window.
Hankmanhub, here's potentially another example (i.e. adcomm approval but awaiting regulatory decision)
Gawd, I put this poster on Ignore after reading a couple of sentences of him/her's crap but you had the patience to tutor him/her. You're a a very virtuous, kind, or patient person, or to put it another way, a saint.
(Very interesting) trend toward greater FDA regulatory flexibility. It will make DCVax-L's approval by the FDA a walk in the park.
JAMA Mia! That's good. Will have to try to use that some time.
You're on to something. Substitute MHRA for ODAC and you may have very well hit the nail on the head.
No IFS, ANDS, OR BUTS about it, A....then B. That's what biotechs do, use every opportunity to spread the word.
Nice find
Gilead and other BPs should hire Ramaswamy as a consultant. This way when they buy these Phase 1b drugs for 5 or 10 billion which then fail in Phase 3, Ramaswamy will never want for a job. BP will need to cough up the dough to buy a biotech such as NWBO w a successful P3 trial for the 'Emperor of all Cancers'.
What's NWBO worth? I dunno the answer BUT it amazes me how big pharma buys these biotechs that have promising early results and crash bigly with their Phase 3 trials. Gilead buying Forty Seven in 2020 for $4.9 billion for the promise of Magrolimab is another example
Yes, I just saw that. Thx.
EDIT: Never mind, got it.
While we are on the subject of trying to figure 'things on the site'. How does one switch between Classic and the full view mode?
Very slightly related to who knows what. Too much of a good thing: Livers of young mice filter out nanodrugs, making them less effective
No matter how many times you hear Docs say this, it's nice to hear/read it again.
That depends. If you read LCs post it's MOOT but if you don't read/see his/her posts, it's MUTE🤔
No; NCT01204684
Several things:
1) the 30 to 45 day submittal of BLA fast approaching
2) Nature Journal preprint available
Dendritic Cell Vaccination in Conjunction with a TLR Agonist Polarizes Interferon Immune Responses in Malignant Glioma Patients
https://www.researchsquare.com/article/rs-3287211/v1
3) Dr Liau joining SAB
https://nwbio.com/press-releases/
A Musing: Just reading about Mesoblast's BLA getting a CRL from the FDA because of an inadequate potency assay and thinking that won't be a problem w the DCVax-L potecy assay. NWBO made sure of that in their development of a 2nd gen assay which was discussed at ASCO 2022 starting at ~minute 13:15 where DR Bosch discusses industry challenges w the potency assay being one of them.
PGSD, it's a poster session meaning Dr Bosch will be hanging out next to his poster entertaining and answering questions between 7:30 and 9:30 PT just as other presenters will be in front of their posters entertaining and answering questions about their posters.
Yeah, and multiple that by ~10ish when Flaskworks is fully implemented.
This link works
Totally agree. Awesome place!
And a Happy Birthday to you! Yes, the key is, as you say, "try to stay moving"! On many hikes, I don't have cell service, or more likely, don't use it except for my tracking app (Strava). Some/most times I'll ponder what am I missing w NWBO stock but it's somewhat fun getting back in the evening and going thru the ihub NWBO board w that rare occasion where some crazy stuff happens. Didn't know what was going on w NWBOs share price yesterday till I got back from my hike but the 8.77% rise "Met Expectations". Doing another hike today, hopefully, NWBOs SP will "Meet Expectations" again when I get home 😜
Impressive elevation. While I've done that type of hike back in the day, I've slowed down some (will be 68 on Thurs). I just did a hike today of 12.48 mi and 2079 ft of elevation getting ready for an upcoming White Mts trip. I won't do more than 3000 ft if I can help it.