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The MHRA (MAA) and/or the NY Federal Court (spoofing case) will likely be the initial providers of the next “useful” news. That could happen any hour/day/week.
Therefore, Human MIA doesn’t need renewal until February 7, 2026, and based on inspection in February 2023 and review confirmation/grant on September 6, 2024, it appears they are well on their way.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175126861
(Edit: September 6 human MIA received, September 10, Human MIA published.)
Thanks. Your document shows that the decision was on September 6, and it was published on the 10th.
Hope he gets better. They should display correct recording date of interviews on their replays.
Outstanding Shares
9/23/2024 1,276,923,405
(not certain what happened on each day between 11th and 23rd)
09/10/24 - 1,268,466,946
09/09/24 - 1,267,466,946
09/04/24 - 1,265,305,732
08/31/24 - 1,262,453,507
08/30/24 - 1,261,586,840
08/24/24 - 1,259,357,313
08/22/24 - 1,258,991,738
08/21/24 - 1,253,573,555
08/20/24 - 1,252,023,238
08/17/24 - 1,251,323,238
08/15/24 - 1,249,656,571
08/13/24 - 1,249,179,758
08/07/24 - 1,248,237,358
08/01/24 - 1,246,675,355
07/30/24 - 1,246,275,355
07/26/24 - 1,245,699,314
07/20/24 - 1,236,477,167
07/17/24 - 1,233,314,821
07/13/24 - 1,232,214,821
07/11/24 - 1,231,614,821
07/10/24 - 1,230,455,122
06/29/24 - 1,229,682,280
06/19/24 - 1,229,013,505
06/13/24 - 1,226,621,118
06/11/24 - 1,226,070,527
06/06/24 - 1,224,429,027
06/05/24 - 1,216,304,027
06/03/24 - 1,213,231,632
05/30/24 - 1,212,733,785
05/24/24 - 1,212,558,785
05/20/24 - 1,211,119,735
05/10/24 - 1,210,879,427
05/09/24 - 1,208,747,616
05/03/24 - 1,208,177,416
05/02/24 - 1,207,516,291
05/01/24 - 1,206,257,975
04/27/24 - 1,205,420,320
04/26/24 - 1,205,197,045
04/23/24 - 1,204,236,917
On September 10, Advent received Human MIA for commercial manufacturing. This seemed to complete one of the major hurdles.
(Also interesting, the day of and the day after clinical trials.gov combination trial masking change to patient only was submitted (September 11), the FINRA short volume ratio spiked to 61.34 and 59.89. The masking change was not posted by clinical trials for eight more days. The Sept 13th short interest in shares and dollars will both be interesting.)
It states dollars on the chart.
The chart is not misleading. It is short interest in dollars. As of the last dissemination, it was about as cheap as can be for shorts to completely cover their old positions. Let’s see how much was left of their dollar interest on September 13.
Prior to that, you’d have to go back to the end of 2021 to see such a low short interest in dollars.
I think they were talking about their theory of financiers motivated to get the price down before financings.
MAA STATUS: June 29, 2024 Flashback (see quote below).
(Note: At this point, some longs are now thinking 210 window started March 7 and Goes to October 3, although everyone (longs and bears) recognizes regulatory speed is variable but improving this year. In other words, MHRA could take a little longer.
August 2 (8k) seemed to indicate inspections were planned during the last 70 day window.
On September 10, Advent received Human MIA for commercial manufacturing. This seemed to complete one of the major hurdles.)
That show creeps me out. They should be required to display a time/date stamp for original recording date of each interview.
No. That’s not the best case for L. Best case is better.
Checking in on chart guy following NWBO.
$NWBO early in the week view Bollinger Bands starting to really contract as price is holding Mid Bollinger Band line - with a side a Monster RSI Bullish Divergence on the Long Term Support Line / Double Bottom pic.twitter.com/7AgFqaWeEa
— 3PuttBogey (@3_Putt_Bogey_) September 23, 2024
https://clinicaltrials.gov/study/NCT04201873
Minor Note: Eight day wait to publicly post after latest change.
Patent flashback. February 16, 2024
$NWBO patent application with status "Grant of patent is intended" on February 16, 2024 by the European Patent Office (EPO) EP14859634 - "Combinations of checkpoint inhibitors and therapeutics to treat cancer"https://t.co/csOzR79JpO pic.twitter.com/U1ZwMZOvtq
— Henry (@HenryMuney) February 18, 2024
Europe. 747 million people.
Ireland. Six million people
Israel. Ten million people
Important:
In the Merck sponsored UCLA combination trial with DCVax-l, Keytruda, poly-iclc, the patients are “blinded/masked”. The sponsor, provider and other parties are not blinded. The change from double masking to single masking occurred on September 11, 2024 and the update was posted on September 19, 2024.
Recently (June 29, 2024), LP stated at the ASM, she wants combination trials with Checkpoint Inhibitors and use tumor “shrinkage” as a faster endpoint.
Recently, the combination trial primary completion was accelerated from August 2025 to December 2024. This update occurred on August 9, 2024.
(Note: The trial began in January of 2020)
(Note: NWBO was granted a combination patent this year including DCVax products used with CIs)
All matching recurrent trials dealt with the same confoundment level. What you are doing is counting on people to forget that the crossover rGBM trial all began with SOC and no DCVax-l. Then, in the DCVax-l recurrent trial, they received DCVax-l upon crossover. They ceased receiving the chemotherapy Temodar after crossover.
You are a distortion master.
Instead:
First, NWBO only admitted the original (but changed prior to data lock) PFS failed (due to pseudo-progression confoundment)
The JAMA article concluded the current Overall Survival endpoints succeeded. This success was in both nGBM and rGBM.
The JAMA conclusions were that DCVax-l treatment helps long time survival.
Dr. Liau joined the scientific advisory board that helps guide the maa process through regulators. Right now, the MAA in the U.K. appears to be moving through the approval review in an accelerated manner.
Merck signed this deal with Daiichi more than a year before its late stage (Originally only Daiichi’s drug) ADC trial with them succeeded.
Deal October 20, 2023
If I had GBM, I’d try to get into an individual study trying DCVax-l + CSF1R + poly-iclc (and maybe CI).
Mice, but it would likely make for a suitable combination trial with DCVax.
Today, Steady T said:
1. Patent Prosecution Highway (PPH). This is a program that allows applicants to fast-track the examination of their patent applications in one jurisdiction based on the positive examination results from another jurisdiction. If a European patent is granted, the applicant can use the PPH to expedite the examination of a newly filed corresponding U.S. (and/or other countries) patent application in lieu of an old/abandoned U.S. (or other country) application version.
NWBO abandoned their latest old U.S. version on April 11, 2024. Two months after the Intended European Comnination Patent Grant was announced. The European patent is broader in scope and appears to include L and Direct (with CI combinations).
European Combination Patent, Flashback February 16, 2024.
$NWBO patent application with status "Grant of patent is intended" on February 16, 2024 by the European Patent Office (EPO) EP14859634 - "Combinations of checkpoint inhibitors and therapeutics to treat cancer"https://t.co/csOzR79JpO pic.twitter.com/U1ZwMZOvtq
— Henry (@HenryMuney) February 18, 2024
It’s not my thought, it’s LP’s thought.
PARTNERING: June 29, 2024 Flashback.
Linda Powers:
Autumn Begins:
Sun, Sep 22, 2024, 8:43 AM EST
How could you possibly know there will be no MHRA news?
You can’t.
It’s that simple. You are giving an opinion.
Note: I don’t take issue with your first two full paragraphs, and although LG chose to fudge, I think there were likely good internal/scientific reasons for those delays.
This seems perfectly suited for a collaboration trial with DCVax-l and DCVax-Direct. TRINTELLIX goes generic in 2026. It is interesting Takeda manufactures it for the U. S. .
One more post this weekend. I don’t think people understand why I posted this. Look at the link and tell me how many countries you see in the consortium in addition to the UK? The program works in BOTH directions.
P.S. We have considerable IP filings in every one of those countries.
Australia: streamlinedsubmission@health.gov.au
Canada: HC.tpd.international-dpt.SC@canada.ca
Singapore: HSA_TP_Enquiry@hsa.gov.sg
Switzerland: Networking@swissmedic.ch
United Kingdom: access-mhra@mhra.gov.uk
https://www.tga.gov.au/access-consortium-new-active-substance-nas-work-sharing-initiative
🍁See you all in Fall!🍂