You got your admin buddies to restore it. You turn substantive dialogue into poster bashing, because you control the rules. Your posts are off topic and I’ve already responded to this one since it was restored by your buddies.

You turn this board into character assassination instead of staying focused on the relevant topic.

“We'll see”

I’m an investor that analyzes and watches his investment. You are a basher that tries to crush companies people hope will solve some of the world’s problems.

You are also highly connected to administrators.

Other way around, typically.

Just FYI

Oh, I found it, stock ticker DUMB.

It’s always such thin trading over there. Is it low volume like here today?

Please start a company. It will be my fist short.

Smh.

Not true. The results are exactly what we found in JAMA, and had you been CEO you would have given up in 2015. This trial took understanding and learning from what the biology had to teach us, not the other way around. If you watched Doctor Bosch’s presentation on MOA you’d understand the immense immunological activity and broad spectrum approach our immune systems have. To capture this initial efficacy, despite pseudoprogression and crossover was a careful scientific endeavor, and they succeeded imo. Now, assuming approval, as LP indicates, we can further harness this power through combination trials at breakneck speed.

You are confused. I didn’t claim this maa is waiting for Eden. They are not waiting for Eden according to LP. I do think it’s quite possible the combo trial is awaiting Eden. It’s fine if you disagree.

I don’t think, imo, that is anywhere in their thoughts at this time.

Linda Powers stated she was hoping for 150 accelerated process. That very end of Sept / beginning of October would approximately fit 150 clock on 60 clock off from March 7.

In a perfect world, (assuming some announcement lag time) NWBO’s hopes could be achieved at this more accelerated pace THEY hoped for.

(Today, on the other hand would fit hypothetical 210 day clock on + 60 days from January 24.)

However, it could be 210 clock on + 60 days from March 7 (aka: Very early December), which would still get MHRA to their target goal, perhaps.

Or, it could be somewhat more delayed. All we can do is watch.

You must admit, perhaps, that it is peculiar that since MHRA started reporting approval lists with bi monthly updates, that in approximately 36 updates, this update is the latest or perhaps second latest, depending on one anomaly in the update history. Coincidence? Maybe. Maybe not. Coin flip.

Nobody knows if a confirmatory trial is/was needed, but I have discussing the analysis if this should be(or at one time was) the case. You simply continue to present your own ignorance by attacking the poster rather than engaging in the discussion at hand.

ChatGPT

Did you see how you just proved your lack of knowledge about confirmatory trials? You changed the subject and attacked the messenger, instead of studying the history. Hint: Keywords confirmation trials.

I don’t pump. I analyze as an investor what appears to be happening.

Please educate yourself.

See posts 726768 and 726756.

You are seriously lacking in confirmatory trial knowledge. The history of confirmatory trials for accelerated approvals once suffered because companies only started them after approvals, and because they did not start them after approvals, they would drag their feet from starting them and then drag their feet towards completing them.

So, regulators got wise and wanted companies to start confirmation trials before any approvals so the companies would not drag their feet.

Here, if this was being used as a confirmation trial,(perhaps one of two confirmation trials, the other one just being completed!), the fact that it almost reached primary completion before an maa decision was made would have been possibly unprecedented. Its continuance is far more standard in these situations.

Also, I am not part of some social media army, dimwit.

The change in the combo trial reverted back to a primary completion date 1/2 year later, after previously reverting in the other direction after yet a previous lengthening.

Importantly, the trial is still recruiting.

Importantly, it’s almost certain, imo, an IA was conducted as the trial was officially unmasked to investigators back on September 11, 2024. Although, as Ex points out, it was likely unmasked for all intents and purposes years earlier.

If it serves in anyway as a formal or informal confirmation trial, its extension in and of itself for more maturity at this point would not impact the maa in the UK imo, as confirmation trials typically continue after approvals, and it would have been rare air for it to complete before an maa decision in the UK.

Moreover, the fact that they want the combo trial to continue/finish recruiting and mature seems quite pragmatic, because, as you know, Eden testing in the UK is not complete, so why not? It is encouraging that the combo arm was not stopped for safety efficacy issues, because Keytruda does often battle side effects, and more mature results later may help any moves in the U.S.

Net net, because I think this trial was examined both over time and recently perhaps internationally, continuing maturity until full enrollment can only strengthen its own role. JMHO.

It’s amazing how many times this needs to be pointed out. It’s almost as if they don’t want to know the answer to things.

On the other hand, it’s probably worth mentioning October 17 is exactly 270 days from January 24. 270 - 60 = 210. So there is that scenario as well I suppose.

To the day, one year earlier, this happened.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175216491&txt2find=Caesar

And Validation confirmation date was PR’d in their 10Q

FeMike’s hypothetical timeline? Give or take.

December 20
MAA submitted

March 7
Validation confirmed

May 26
80 day target missed by MHRA

July 9 RFI

August 1
Future inspections scheduled

September 6
60 day response to RFI completed.

September 6
MHRA grants human Mia (expansion?) based on earlier inspection and later review

Today October 16
Inspections possibly completed or near completion.

November 16
MHRA 70 day second phase target date for decision.

One of many Alternative hypotheses to FeMike’s hypothesis

May 26
No RFI issued/necessary

June 29
Field inspectors not yet available.

July 25
Phase II 70 day reviews initiated Q&A
Future inspections scheduled.

September 6
Human MIA granted on expansion based on old inspection but recent review.

October 3
Phase II target date status?

Continued: Oh, I see, you were guessing.

Thanks for this clarification.

Not certain what you are saying. Just a post or two ago, you opined all the inspections may be complete. In other posts you opine maybe not. Guessing like the rest of us.

LP stated they weren’t going to update interim
matters. I doubt they did. LP stated they would update when there was a final decision. I’d imagine that goes for over the phone as well.

Also, I didn’t call your assertion that NWBO inspections always take longer a “ridiculous” assertion.

I merely challenged you to provide examples, and you provided examples of Covid delays and MHRA resource delays.

That would be insider info. She would never do that. Senti is probably just thinking December and allowing for January.

Oh, I didn’t catch your word “posture.” I see what you mean.

Based on?

Actually, I’m kind of glad nvcr found a different niche to survive.* In its own way, this is conducive timing.

* Still highly doubt I’d ever use ttf.

Presumably. 🤓

Actually you probably need to subtract 60 days from 222 and also subtract any announcement time lag. The number you arrive at will equal clock on time. Clock on time is what all those MHRA target dates and accelerated 150 day programs measure.

And why does the MHRA occasionally but rarely wait this long before announcing their biweekly approval list? Maybe the MHRA announcement policy?

Just a what if….

This chart reflects that the data is updated through October 1.

October 1 is also one day after the last biweekly approval list cutoff. It’s still not been released.

Just a thin possibility this time around, but still a possibility.

I think DennisDave has a good point, and one I’ve made more generally before. The reduction in backlog will ultimately shift more workers from IRP to national route and thus speed it up even more. IRP has biologic reviews as well as chemical, so I’d think this point is well taken, but wouldn’t go as far to say it will impact DCVax-l’s review team composition. If it did, it might have been an increase in field inspectors.

Thank you. It really is amazing what MHRA has been doing. In one month alone, their total work on hand has gone from 490 on September 2, to 353 on October 1.

(Mostly thanks to their IRP program. I think more countries, including the U.S. will take another look at the UK’s success and consider something similar.)

Look again.

The minimum is really around 150 days clock on.

So if you multiply a 208 day average with three participants, that’s a cumulative of 624 If 150 of those are for accelerated, that leaves 474 for the remaining 2.

So that would be

150 day average clock on for one.
237 day average clock on for two.

That approximation could be distorted by outliers, but I doubt there were outliers below 150, so….

NWBO is currently 222 - 60 = 162 days clock on (approximately) if normal clock off days happened, and normal announcement lag are in play.