While RFIs can be issued on occasion during inspections, those being reviewed try to answer on-site, thus avoiding the need for any rfi at that stage. Remember, one of the largest inspections already resulted in human mia certification by MHRA; and on the clinical side, nwbo’s contractors, which include previous inspectors, prepared for inspections for over a year.

ChatGPT below:

Gary, I don’t think that’s what happening with the MAA.

(Prayers to Middle East. All citizens caught between their leaders’ egos, self-righteousness, need to control and testosterone)

Here’s a word for governments around the world.

Tolerance.

Merck missed Moderna on way up (virus treatment) then caught Moderna’s falling knife on the way down (cancer treatment).

Yo, Merck, we won’t let you down, but we’re gonna get swooped if you don’t move, imo. 🤟

Yes, that’s typical, according to some ai sources, for what that’s worth.

LP wanted her team ready if an RFI was issued. So she assumed one would be issued to keep readiness. We are now at the stage, and certain public comments and schedules make it conceivable they passed that need. IMO.

I disagree. The point of being accelerated and have target deadlines is to meet those deadlines.

The MHRA is most concerned right now with keeping it at 210 days or less (not counting clock off, which we may not have used). So even if this was 150 day procedure target, 210 day completion is still important.

Why would they hurt their stats if they got their inspections done and everything checked out? They would not, particularly on something so good the original maa was not changed, an rfi might not have been needed, and clock off time might not have been needed? Something
so urgently needed it probably received accelerated review?

Wrong? Not likely. It seems like what one might consider “wrong” was really just the MHRA catching up. That’s why it was nice LP scheduled the ASM when she did.

The 80 day letter, rfi, should have come back in end of May, but it didn’t. There may never be an rfi. They had some dead time while MHRA tried to find inspectors available to inspect (there’s your unaccounted for 60 days (end of May to end of July), imo. They had an ASM June 29, 2024, the process of inspection scheduling occurred sometime between then and August 2 for future inspections. Voila.

We all know from prior MIA stuff, getting inspector dates is tres difficile.

Jmho

Whether an RFI is required depends on the completeness and quality of the submitted application.

If the application meets all the necessary requirements and provides sufficient data for evaluation, the MHRA may proceed without issuing an RFI.

In other words, an RFI is situational and depends on the specifics of each MAA.

No, if you are counting it your way, that is with an rfi + 60 days clock off, you’d be counting 297 (237 + 60). Aka late January not late October.

Fortunately, I don’t think that’s what the situation looks like.

LP said these things are not right “on the button” even if they are accelerated.

Actually, not accurate. We are a subsection within that, that is if we are accelerated.

LP thinks/thought we are accelerated as recent as June 29. So the 237 average days arguably does not apply.

There’s more to unpack here, but I’ll leave it at that, other than to say they do not include the 60 days clock off, if there was an rfi.

With DCVax-l, there probably wasn’t an rfi by June 29, and inspections were scheduled shortly thereafter, so….maybe no rfi. So maybe no clock off.

Reposted for DennisDave. Dennis and ChatGPT, we are in 2024.

MHRA SEPTEMBER 13, 2024 (83% BACKLOG REDUCTION)

In other words, Viking apparently thinks it’s under the accelerated process.

Instead:

210-day timeline: The standard timeline for processing applications for medicine approvals (Plus any clock off time)

150-day accelerated assessment: A faster timeline for high-quality applications that meet certain criteria. (Plus any clock off time)

These dates are if there is no formal rfi and thus no formal clock off time.

LP thought on June 29th we were probably following the accelerated process, but MHRA target times are not always on the button. There are reasons to believe that may be accurate.

By June 29, 2024, NWBO had apparently received no rfi. That’s weeks past when they should have received an rfi if they were going to receive one. Next thing we know, inspections had been scheduled sometime by or before August 2 for future dates. Inspections are usually scheduled for last phase of maa review. Next thing we know, by Sept 6, the human MIA was granted allowing human commercial manufacturing of cell products at Sawston.

It can be, yes. They didn’t refer to it as such though. In the end, no changes to the maa were required. In the end, it appears the clock started March 7, 2024.

Incorrect. Instead, the 10q includes both the January 24 validation date and the March 7 validation confirmation date. The company also stated there were no changes required to the maa in order to receive confirmation validation.

They received forward investigation scheduling
(Which typically occurs during last 70 days) on or before August 2, 2024* and their Sawston facility received human mia certification September 6, 2024, and today is 210 days from March 7, and as LP stated on June 29, while they believe (can’t confirm) they are receiving 150 day (+ maybe 60 day clock off time) accelerated treatment, time schedules at the MHRA don’t necessarily happen “on the button.”

Note: If there was no accelerated treatment, but also no rfi, then 210 is normal timeframe. But, again, not necessarily “on the button.”

*arguably on the button.

Your interpretation is Incorrect.

MHRA SEPTEMBER 13, 2024 (83% BACKLOG REDUCTION)

PPS wise, you only need to know that with each step closer to likely approval, the downward price pressure escalates.

Management knows this, so, if they are lining up their ducks to break out of this price suppression, would they put their backers, heavy hitters, agreement announcements, resources and the like on the front end or the back end of marketing approval? Again, at this point in time, knowing the pattern of price suppression punishment responses for pre-approval NWBO positive progress events.

Your position demonstrates a failure to recognize the potential monetary value for a new cancer treating paradigm, post initial marketing license and hence proof of concept, that is at once safe, efficacious, easily combined and enhanced with checkpoint inhibitors, csf1r, poly-iclc and other adjuvants; your slumbering position also fails to calculate future near term value and temporal enhanced manufacturing for autologous dendritic cells, and your position ignores Direct IP, CI combo IP, hyperactive dendritic cell IP and optimization IP.

It is easy to write these off if you are a casual skeptic, but BPs can’t afford to sit on their hands after DCVax-l initial approval, because it provides an entirely new keystone to improve cancer treatment. Moreover, the CEO is now confident additional indications through combinations can be demonstrated very quickly via tumor response/shrinkage trials. That information is clearly about to become more evident, imo, from the combination trial with Keytruda which recently sped up its completion date and just unblinded all investigators. The fact that DCVax-l was recently issued a European patent grant for combination therapy with BP’s most lucrative but patent cliff awaiting platform provides compelling value potential for an entire industry in need of nontoxic therapeutic partnering.

DCVax’s likely application to all solid tumor cancer can easily be projected by its broad spectrum mechanism of action. The issues of running into huge safety stumbling blocks and quantity limited restraints, like Car-t technology did, or bouncing up against provider resistance and dissatisfaction, like tumor treating fields has, is determinately minimal ahead of time.

Judas was a disciple. All the disciples and Jesus were Jewish. Aside from Judas (perhaps), they were trying to move global society away from ideas like an eye for an eye, and instead, do unto to others as you would have others do unto you.

They were trying to promote multicultural tolerance, being good Samaritans, hate the sin but not the sinner, forgiveness and mercy.

They tried anyway. It’s pretty violent out there right now though.

Your perspective is a good example of why some pharma’s fade because they don’t recognize and invest in sound science and manufacturing potential. Your loss. Next bidder please.

Hope this U.S. continuation patent application perspective helps in context of what appears to be going on with combination trial.

I’ve edited this down.


ChatGPT

Right, and I do it too, but don’t forget to say patent applications when you don’t mean patent. It’s easy to leave application off and confuse.

The U.S. parent combo patent applications were abandoned, but there are two unpublished continuation patent applications pending.

Right now, Henry can correct me if I’m wrong, Europe(a continent obviously), Israel, Ireland, Hong Kong, maybe Japan and if memory serves Switzerland and a few other countries have granted the combination patent.

No, tomorrow is 210 days since March 7.

If 150 days accelerated + 60 days clock off, then yes.

Or

If 210 days non-accelerated and no clock off (if no rfi) then no.

Or

(150 day + 60 back and forth) Hybrid accelerated
There is a decent chance there was no formal rfi, but informal back and forth, which could make the 60 days clock a little hard to label.

Or

Something else.

lol. You wrote a post but forgot the writing below the link was my quote.


Do you mean patent or patent application? If you mean patent application, the facts have been laid out in this thread.

The parent patent anpplications in U.S. are “abandoned” in the filings but they continue on under new patent pending application numbers, and as you say, not yet open for public viewing.

IMO, they are probably going to apply under the broader and recently granted European patent. Just my humble opinion. I believe that will be even smoother once the combination data is formerly published.

They did not “hide” the results. They are still collecting data on those results.

Now NVCR hides results. They shut down trials and stop collecting data when their survival results began to decay.

They knew the endpoints were confounded by pseudoprogression and crossover, which could easily be learned from the compassionate program and informational arm. They did not and have not confirmed the original OS endpoint result, and you are wrong to be 100% certain, particularly because you’ve admitted some uncertainty in the past (due to ltfu possibly being located). Regardless, the endpoints were changed while the trial was still blinded. The trial succeeded on its primary endpoint utilizing external control arms for nGBM and rGBM. A strong finding of efficacy conclusion was published in JAMA.

You’ve also admitted that if it turned out the original OS is even nearly significant despite the crossover, it would be impressive.

⌚️From Friday, August 2, 2024 (8k revealing future inspections had already been scheduled at some point prior)

Added 70 days

Result: Friday, October 11, 2024

As discovery finishes up in Harrington case, Magistrate was suggested for settlement conference, but yesterday, one or both parties declined settlement negotiations.

⌚️From Thursday, March 7, 2024

Added 210 days

Result: Thursday (Tomorrow), October 3, 2024

Bigger confirmed he holds over 30 million shares yesterday.

He just confirmed he owns over 30 million shares. You sir, are a fudster.

Incorrect. You’ve been inferring Bigger took off for years. You do this to create fud. Here is an example of you doing just that by inferring Bigger ran away.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175161011

Dr. Rago did not disappear “dude.”