Part B is 28 day inpatient with up to 40 subjects.

It says 40 subject for the trial which includes part A&B. It looks like those subject in part A would not be in part B
So how many are in part B is not clear.

It remains to be seen what returns NWBO will deliver.

I'll take my chances with management, whatever mind set you think people have.
The science will override your opinion.

Good luck.

Instead of a thumbs down emoji, how about answering the question?

Nothing quite like a personal attack when you have nothing else to work with.

Where did you get the information that the second cohort of part A was complete and that portion of the trial has completed?

Yeah..... I'm sure in your world that is the case. For those of us that live in the real world, not so much.

There is no such thing as consistent shareholder returns for a pre approval bio tech. That is a straw man.

He was booted. Don't know why.

You may have noticed that the entire market was down today. Anavex was no exception.

In today's woke world this sentence can have two meanings. I see humor in that. And yes, I know what he meant.

Yep.

Sense of humor challenged?

Not quite sure what you mean with this.

Your use of the word "improvement" is very misleading.
There was no improvement in AD patients.

What there was, was a slowing of the rate of decline by about 27%.

There is a big difference between improvement and slower loss.

No big pharma is interested at the price NWBO wants, is probably closer to the truth.

They are betting that the MAA won't be approved. That is a bad bet.

Lol. Kund and reasoned criticism do not belong in the same sentence.

I assume you are using the royal "we" in this sentence, for surely you do not speak for most on the board.

Have you ever considered that a different CEO might be worse?

Guess what? This is a message board, not a court of law.

As far as news organizations, most have no idea how to spell TLD and have zero interest in reporting it.

Approval by the UK EMA confers legitimacy to both the drug treatment and its method of action. At that point the unproven become PROVEN.

Because DCVax-l is a treatment for one of the most difficult cancers to treat AND because the MOA can be applied to many other solid cancers, main stream media will be doing stories about NWBO and DCVax-l. Why? Because cancer is a feared diagnosis so it gets people's attention when there is a new treatment that offers real positive outcomes.

And yes, it hinges on IF NWBO is approved.

Hide and watch.

Depends on who's making money off of the SP doesn't it?

First of all there is no such thing as "Wall Street". What exists is a wide variety of players, each with its own modus operandi and motivations.

NWBO is a developmental biotech with a new approach to treating cancer that has not been done before. That makes it risky to many investors and institutes. Then there is the share price that scares away the vast majority of potential investors and prohibits many institutions from investing in NWBO.

Add to that the very long history of NWBO that has not produced a product and its very large OS. Oh, and don't forget the shaky financial situation of the company.

So, with all that in mind it seems pretty easy to understand why the share price is not much more than it is.

And, I haven't mentioned the short hedge funds and short traders, who have a strong vested interest in seeing the share price go down. Those folks work at their job. SEC enforcement actions show the types of dirty tricks that are used in the marketplace by "Wall street", or at least a small segment of the investing world.

Once there is an approval of DCVax-l the situation changes. The unproven treatment becomes validated and proven in the eyes of many investors. At that point they will begin to pay attention to the drug potential and the word about NWBO and its new treatment will spread.
The biotech investor funds will take NWBO seriously and start to buy shares. News organizations will pick up the story which will create additional awareness of NWBO.

It all hinges on approval. After that I think the stock will be higher than 30¢.

I sold some of my other bio tech and rolled that money into NWBO. I'm hoping NWBO makes a move before the other one does.

Hard to tell. If you look closely you see the **** in the foot notes. That is a note to the work on hand numbers.

What is scary about that is that it says biologics are removed from those numbers.
That tells me that the biologics could be even further behind. Given the huge size of the filing, NWBO could be taking a lot longer than the statutory time frames.

It would have been helpful if the biologics had some information on them as a class.

If I understand that PR, that means they are running behind schedule and are catching up. I wish they had said how far behind they are.

So that implies that any guesses based on the 210 or 150 days plus clock stops are likely to be underestimating the decision time.

I bought another 10K shares today.

US produced shrimp are less than 10% of the US shrimp consumption.

Maybe the board has more information than you do and is happy with the company's progress.
Arm chair quarterbacks are never wrong it seems.

Did you add in clock off days?

We ended up 21 pennies. You should have wood.

Looks more like 1 year's experience 20 times. 🤣

I just went back and rechecked the EMA data on the AA applications and I got the numbers backwards.

There were 11 applications in 2022 and 7 were REJECTED and 4 were APPROVED.

My bad.

No argument about the current share price.

However, you said it is probably a little premature to talk about potential value.
If you think that is the case I do wonder why you hold shares if you didn't think the potential was there.

I agree that the MAA submission is the next critical step, followed by the NDA submission.

We have a semantic difference over the distinction between price and value. Not that big a deal. The share price is what it is and it isn't what any of us would like.

We just might. Then again we might not. As Yogi said, making predictions is hard, especially about the future.

So the P3 trial that is about to be submitted to the EMA has little value in your estimation.
The other drugs in the pipeline have little value in your estimation.

I am reminded of a phrase that Warren Buffet uses on occasion.

"Price is what you pay, value is what you get."

It appears to me that you are discussing the share price of Anavex and assuming that is also the value of Anavex.

I think that is a mistake.

We shall if that is true or not in the coming year.

In 2022 the EMA had 11 applications for AA. Of those 11, 7 were granted.

Apparently the EMA doesn't use AA often.

Since the MAA has not yet been submitted as far as we know, AA is still on the table.

Below is from the EMA website concerning Accelerated assessment.

What part of the word "potentially" is giving you difficulty?

You answered a sentence that speaks about the future with a statement about the present.
Non sequitur.

Potentially.

I would like the techies to give us an update about why the 503s were happening.

No one suggest that that the EMA got down on its knees AFAIK.

My point, which seems to be at odds with your view, is that it seems quite possible that in the discussions that Anavex had with the EMA (CHMP people) that they liked the data that Anavex showed them. They expressed a positive view.

Even if they did say please submit, the CHMP will go through the full submission file which will contain much more information that was shown in the discussions. The CHMP will make its recommendations based on the full submission file and whatever was said in those previous meetings will be a distant memory and have little to do with what the CHMP decides.

I'm not reading much into the tea leaves.

It really doesn't matter exactly what was said. Anavex still has to make the MAA submission no matter what was said.

Glad to help.

The FDA is not the EMA.
As we have seen by the rejection of the mabs.

The EMA has a different problem than the FDA. The FDA approved the mabs so there are drugs on the market for AD
The Ema rejected the mabs so the EU needs an AD treatment that it can afford and make available to all EU countries that don't have the infrastructure to support the mabs.

I don't doubt that the EMA looked at the data that Anavex presented and said, that looks good, please submit so we can take a deeper look.

That comes as a surprise to many of us.

That explains why you are here?