Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
No, not in any real time sense, an RFI issued by the MHRA is not comparable to a Complete Response letter from the FDA.
If a company like NWBO received an RFI, it is a far more common occurrence than not. In the 150 day review process, it gives a company an additional 60* days of “clock-off” time to clear up any issues the MHRA may have encountered during their first 80 day review. (After which the remaining 70 day clock-on review resumes)
Contrast this with a complete response letter from the FDA, where a company must inform the public of real concerns found by the FDA, that can’t (typically) be remedied in a short time frame.
* (On rare occasions, clock-off time during the MHRA process may be extended by yet another 60 days to allow the company further time to respond)
10q Next Friday.
Flaskworks is moving forward to complete
validity tests for the commercial grade unit version and then once approved, to commercially manufacture and ultimately transition from commercial artisan manufacturing to commercial grade automated closed system manufacturing — aka: Eden.
The prodigy system admits it has “limited open handling.” They admit they use plastic bags at separation as well.
Eden does not use plastic bags.
NWBIO
Prodigy uses plastic bags and still has “limited open handling through the process.” Fail
Cacoon cannot handle dendritic adherent cells.
Cell shuttle does not handle dendritic cells.
In other words, you have no examples of patented commercial systems capable of making commercial dendritic cell therapies to treat cancer, and the example you gave of an adherent cell manufacturing system for trials admits its process has “minimal OPEN handling steps.”
Your example still uses plastic bags:
“Italy — the drug failed the confirmatory trial so was pulled.” Exwannabe
I see, so you have zero, not “many.”
Name a dendritic automated closed cell manufacturing system commercialized and making commercially approved dendritic therapies for cancer. Name the company and the model.
Looking at Doctor Liau’s comments over the years, and the four censors previously isolated in the noncrossovers, I suspect the noncrossovers from placebo did worse than any bear here believes, and I suspect those censors will be located and converted to early OS events. I think that long term follow up public dissemination will come on the heels of NICE valuation.
There is a point, whether or not an rfi came as one letter or a series of information requests, that the response is concluded. FYI: One of the new approaches by MHRA is to (try to) limit RFIs to one letter, which is why they now stress well pleaded MAAs must be initially submitted.
It’s dismal what spoofing pressure over the years forced NWBO to finance at and the types of loans obtained. Hopefully that spell will be shattered soon. Damages.
If we had an RFI, who here thinks NWBO already responded?
Exactly.
One doesn’t spend for commercial Eden facility expansion at this point and time unless one is confident in approval and the approaching need to ramp for further UK demand. IMO, it’s that simple.
Interesting grammatical tense selection.
Inquirig said:
For what it’s worth, while I still believe an MAA decision could come any day, studying the NICE STA timeline again, scribbling down external comments and events, and looking at the 150 day MHRA process (room for flexibility) over and over, I think FeMike might be closest with an end of June aspiration. While I don’t agree with him that's the best one could hope for, I do believe that’s somewhat more likely than anything earlier or later.
I do believe some potential intervening preceding events, publications or deals for instance, still have a chance to catch many off guard.
Stonkmaster, I noticed your countdown repeated itself around April 29th and 30th.
We are actually 134 days from submission, and everything else is a day different as well.
No criticism, just letting you know.
I like that structure one prerevenue company did, wherein a large investment firm gave a huge cash award in exchange for a fraction of a percentage of future profits. Of course, we may not even need something like that, dependent upon what negotiations we’ve worked/are working out with other pharma.
Hopefully, we’ll soon have something better than loans.
I’m hoping the true up case is discussed in the 10q.
I assume the former. Logically, the Judge wouldn’t reask.
10Q due approximately May 10, 2024.
The documents will eventually be available to non-subscribers like me and apparently you. Some folks on X are likely preparing a summary for today. For now, it’s just important to know the case is still moving forward, and Plaintiff’s response is due May 31, 2024. Someone currently reviewing what was just filed will probably let the public know if any new arguments were set forth in Defendant’s motion.
Motion to Dismiss and accompanying documents filed by Defendant last night. Plaintiff’s response due by May 31, 2024.
https://www.courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/?filed_after=&filed_before=&entry_gte=&entry_lte=&order_by=desc
You are officially an idiot. Not once in my post did I speak about shorts.
There are a multitude of ways to escape the gravitational dilution field for a battered company once an approval, unanticipated by the market, occurs.
Up front cash from several potential franchisees, or
Up front cash from one or more partnerships, or
Up front payments leading to buyout.
The point is, one of the reasons we are being crushed is to force us to finance, dilute and remain poor. If we are flush with, say, a minimum billion dollars cash, the incentives for hedge funds and vultures to keep their boots on our throats disappears.
Agreed, imo.
Should see new MTD from Defendant Market Makers at this link around midnight or earlier. (Could be a little after midnight due to electronic filing to publishing gap)
https://www.courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/?filed_after=&filed_before=&entry_gte=&entry_lte=&order_by=desc
April 18, 2024 Car-T FDA Black Box warning now required.
The next spore trial will involve the formula of (DCVax-l + polyiclc) + plx-3397. That is exactly what comes next. They have the safety and efficacy track record that allows them to move forward. The above combination will be, imo, a cure for many more patients with various cancers. It should have started years ago, imo, but they developed a safety record first.
Think that’s not important? Look at Car-T. Because they did their long term studies after approval, they now know their therapy can cause multiple other cancers, and their transgene can stay in the body for decades causing other mutations. As of April 18, 2024, Car-T now carries the strongest “black box” warning, and patients must return for surveillance for the rest of their lives.
While not accounting for possible compassionate use of the combination, that trial was used to determine the preferred formula for DCVax-l in GBM and Grade III Glioma patients. Poly-ICLC is an adjuvant. There is enough safety data on it to fill the library of congress. Nobody other than UCLA has ten year safety data on DCVax-l + poly-iclc. By itself poly-iclc is ineffective against GBM. As an adjuvant with checkpoint inhibitors, poly-iclc is ineffective against GBM. However, with DCVax-l, this adjuvant formula is safe and appears to increase efficacy.
In that small trial, the DCVax-l + Poly-ICLC arm showed:
100% unmethylated GBM (idh wildtype) patients lived over two years. (n = 4)
100% methylated GBM (idh wildtype) patient lived over four years. (n = 1)
100% Grade III brain tumor patients are still alive. (Between eight and twelve years). (n = 4)
https://www.researchsquare.com/article/rs-3287211/v1
Yes, the trial did not power itself for survival, but the results in that arm are nonetheless stunning.
So I’m not certain people realize what’s going on. A few once promising immune approaches
are dropping by the wayside. Gilead’s program, using an antibody targeting a protein (cd47) on both healthy cells (whoops) and cancer cells was discontinued in blood cancers and all solid tumor cancers. Additionally, Standard Car-T therapy against proteins (bcma and cd19) expressed by healthy cells and blood/lymph B cell cancers received a black box (April 18, 224) warning because it can cause multiple other cancers and/or stay in the body, as transgenes, causing other mutations for decades. Similarly, Infiltrating lymphocyte therapy, which first uses chemotherapy to destroy the immune system cells, was halted a few months ago and restarted due to grade 5 adverse reactions. Also, Company after company going after one or a limited subset of cancer antigens are not able to avoid tumor escape. Most of them readily admit this.
The new head of engineering and manufacturing at Advent is not most recently from Roche, he is from Autolous (six years) a Car-T company hit hard by the scientific outcome of Car-T therapy. Through no fault of his own, the Car-T therapy industry is dealing with very serious safety issues.
All of the strategies employed by big pharma above knew going into it that they were risking either safety, tumor escape or both, but economics, intellectual property and/or other hurdles pushed them into questionable or outright poor and very expensive risks/decisions.
Essentially, Gilead’s cd-47 program was shut down by the company due to overwhelming safety concerns. That’s not surprising, the protein they were seeking to block, the “”don’t eat me” molecule, is found on healthy cells throughout the body, not just cancer cells.
* Gilead gives up on $4.9B antibody as solid tumor plan unravels
https://qtx.omeclk.com/portal/wts/ue%5EcmQ6fDTqbb7gFaA2TyqmveE4b6dzMN9fA7fPsTa
April 18, 2024 Car-T FDA Black Box warning now required.
Wormhole.
May 1: Defendant’s new MTD due.
May 6: “Several” month gap from February 6th (or earlier) begins. Time (minimum) from when NWBO assigned contractor to make GMP grade Eden.
May 10: 10q due.
May 24: Estimated 80 + (possible 60 possible rfi) = 140th day since validation. Cemented?
May 31: Plaintiff’s response to MTD due.
Clown. Try looking in the filings before you make accusations.
It’s in the amended 10k asshole. I’m amazed how you make unfounded accusations when you don’t bother to read SEC filings.