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Funny, dual citizen too, since April this year. Must be that kind of a year.
Excellent article, thanks trickledownfacists
Some snippets below. The whole article is easy to read and makes great sense.
Bought more shares
I take this deal to be positive. Biotech before market access have a constant need for funds and making sure you have a relatively comfortable runway is a must for many reasons, including the possibility of a BO where the Company would not want to be in a weak negotiation position. And $22+ is a pretty good PPS given where the price has been over the last couple of years.
Anyways, I was hoping to get in at around $20, I ended up over $21. You have to get them when you can.
Best of luck with your investments!
Norse 2 TLD: Q3 2021 !!!
They have been consistent in their planning. This is great news.
The Q1 22 for BLA planning is also consistent with a Q3 TLD; It would be a fairly fast submittal, but doable.
Thanks pfelgueiras.
Best of luck with your investments!
Since 2013 and doing great with NWBO, at least on paper :) One of my best investments actually.
Yes "we" long term holders are not all that disappointed.
Best of luck to Patients, NWBO, and Longs!
Nice find.
In case that very recent tweet about not being blinded is no longer actual... Maybe, just maybe indeed.
After all, it's June, it would not be completely crazy :)
Best of luck with your investments!
Best wishes Gary. Your keep your spirits high under these difficult circumstances, my hat off to you. I hope you recover well and enjoy a great life.
Cheers!
Thanks thermo,
It's because of you I'm in OTLK. I bought at $1, when you posted on the NWBO board back when. I looked up OTLK and it went up really quickly. I'm grateful :) !
Best of luck with your investments!
Hi Gorilla,
Dr. Liau is planning on more trials, starting with Direct, combos. She is looking forward to trial design, end points, placebo (or not), etc.
And not only for DCVax, but for the entire SPORE program. She learned from past and current trials and wants to apply lessons learned to new trials.
Best of luck to Patients, NWBO, and Longs!
Dr. Liau is honing her presentation on GBM, failed trials, control groups, biomarkers, trial design, pseudo-progression, all around DCVax-L.
If Dr. Liau thought the trial had failed, I very much doubt she would keep on presenting. She would look at other potential cancer treatments against GBM and not waste her time that way.
The last couple of presentations explain the rationale of the new endpoints. And it may well be a preview of how to articulate the arguments in a BLA the 4 RA's for approval, a journal publication, her peers...
Imagine the diagram of n control groups from historical trials (and some failed treatment groups too). And then add the treatment group from the PhIII trial. Just that one slide would be awesome.
I take her keeping presenting this arc as a positive sign.
Best of luck to Patients, NWBO, and Longs!
No kidding. I'm staying long for probably another year or two, unless I see red flags. I'm not at the moment.
Best of luck with your investments!
Volume: 320K shares ... PPS: -13%???
That's a weird combo. I don't see the news that would drive the PPS down like this. And on an average volume, that looks 'strange'.
Best of luck with your investments!
Now 7 commercial therapies, including bluebird bio's and Bristol Myer Squibb's CAR-T therapy Abecma® and Bristol Myers Squibb's BREYANZI®
543 clinical trials in regenerative medicine
That's why this is such a great company. The 'picks and shovels' of the gold rush!
Q1 Revenue Climbs to $53.3M!
http://ir.cryoport.com/news-releases/2021/05-04-2021-210554092
Given the bears' relentless effort to discredit the company and the trial, the unusual step to publish a peer reviewed article close/together with TLD makes a lot of sense. Bears gin up with all kind of pseudo scientific mud on a daily basis.
Once a peer reviewed article is available, those attacks will lose their bite.
Best of luck to Patients, NWBO, and Longs!
https://nwbio.com/question-submittal/
I hope shareholders do ask questions for the ASM.
Best of luck to Patients, NWBO, and Longs!
49.1% survival @ 3 years for Methylated Group (131 in trial)
Your friend may have some bad information on the trial.
Best of luck to NWBO, Patients, and Longs!
ASM: April 30th (DEFA14A)
Hi Nick,
Great message, she deserves praise, that's for sure.
I found it interesting that she acknowledged your sentiment. IMHO, she implicitly agrees with your message, in particular around DCVax.
That's a strong clue., as Dr. Liau is one of the few people who has seen the data and the PI on the trials.
Best of luck to Patients, NWBO, and Longs!
Thanks so much for the slides.
It's not a direct talk about her own DCVax Ph III trial, but those slides are very big clues in terms of how one would approach the new endpoints!
She is addressing the rationale in choosing External Control Groups (slide 20) and what set(s) would form a good comparison. I would posit those are big clues as to her thinking, either for a journal or for BLA.
And other clues in terms of the McDonald, RANO, iRANO, failed trials...
Excellent.
Best of luck to Patients, NWBO, and Longs!
Funny and on point anders :) Ex gesticulates in all kinds of sad clown ways.
Cheers!
Excellent find Lykiri!
Best of luck to Patients, NWBO, and Longs!
CYRX expands its global reach: APAC!
http://ir.cryoport.com/news-releases/2021/04-06-2021-133206815
Updating CT.gov
Hi VuBru, great write up and thoughts.
On the CT.gov update, given the following is now public, I do not see any reasons for the Company not to update CT.gov with the updated endpoints, be it for a journal article or simply to square things. (I spaced it a bit to make it more legible).
... And the OTLK PR on Norse III
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-safety-profile-norse-three
Positive results from NORSE THREE study in retinal disease
Mar. 31, 2021 8:20 AM ET
Estimated Study Completion Date
"The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study."
Hi Sushi,
Does that mean that they will backfill whatever TLD work to include those last data points, hence a relative short time for TLD PR there after or something more lengthy to TLD?
Thanks!
Best of luck with your investments!
IQ, OQ, PQ
NWBO keeps moving forward:
Hi Maverick,
Isn't that our friend Dr. Ashkan at King's College :) ?
Thanks!
Best of luck to Patients, NWBO, and Longs!
Data Lock & CVM
This may shed some light on timelines for NWBO.
CVM announced data lock on Dec. 7th.
https://www.irdirect.net/prviewer/release_only/id/4556977
Today's PR says:
Thanks BB,
That was a very king gesture on your part. Wishing Basin's friend the best!
Cheers!
Hi BB,
Please do not post a third party phone number here. I can tell you are coming from a good place, but not all readers have the same mindset.
Offering your email was probably the 'right' way to do so, so you could then share more info with Basin.
Moderators, please remove this post. Thanks.
Best of luck to Patients, NWBO, and Longs!
TLD (open-label) NORSE THREE on target for Q2 2021
This is the kind of news I do like to see from a biotech company planning to submit a BLA in Q4/2021. It means the pieces of the puzzle are falling into place and the planned timeline looks good.
This PR is about Norse 3, but you can see how it all plays in their building the case for the BLA submission.
I hope the Company keeps PR'ing these types of milestone. Very encouraged.
Thanks Thermo,
I appreciate your thoughts. I definitely helps me. I'll be in for at least until the tld later on this summer and then I'll see where this might go.
And if you do have the time to put together more info ... :)
Cheers!