I'd be happy to sticky your high quality analysis, if you had one.

See my other post on the Part A data being released.

I haven't done the math so I can't say where the Part A trial was 78 + days ago. There had to be at least a few days after the data was unblinded for the number crunching and PR preparation so when did the Part A trial end?

Since we have data from the Part A and the trial description says safety follow up for up to 78 days for Part A there are several possibilities.
1. The Part A completed more than 78 days ago.
2. The Part A follow up was less than the max of 78 days.
3. The Part A data was unblinded before the completion of the safety follow ups.

My guess is 2.

Good point. Safety data collected "Up to 114 days" .

Interesting that is indeterminate.

Presumably if they don't see any issues they can stop collecting safety data sooner.

How do you come to the conclusion that there will be no FDA BLA submission in 2025?

I asked IR about that. The response was 40 total trial.

I agree that it is POSSILBE that Anavex might release Top line Results by EOY.

Full analysis of all of the extensive list of outcomes is going to take a significant chunk of time. Most of that can be going on while the 3 month safety follow up period is going on. I do not have a feel for how long the genetic sequencing is going to take. Perhaps Doc could weigh in on that.

Patients being dosed does not mean the trial is fully recruited.

They will start dosing patients as soon as they are recruited and they are still recruiting to get up to the trial number of subjects.

Even so, it is good news to hear that Part B is underway.

If the specified number of patients is still 40 then there will be 24 patients in Part B. If it is 50% placebo then they are treating 12 patients. Pretty small numbers.
The P2 trial is a go / no go trial for the P3 and if it is a go will provide insight into the needed size of the P3 trial.

They may finish dosing by the EOY. Obtaining all the secondary outcome measures will take some time. They include :

There is an additional point to be made. Clean rooms come in different grades with the more stringent requirement grades being very much more expensive to build and operate.

Part of the benefits of the EDEN units are that they can be used in a lower grade of clean room thereby reducing the costs of production considerably.

I think that is what you were referring to.

I can think of two reasons to not file with the FDA until MHRA renders a decision.

First is money. MAA approval will provide opportunities for funding due to a real revenue stream that currently don't exist.

Second is that any questions or issues that are discovered in the MAA process can be fixed before the BLA is filed with the FDA thereby increasing the likelihood of FDA approval.

I get the support for PM if mutant is not stat sig. How is that helpful for approval?

You can question whatever you like, whenever you like. It won't change anything that MHRA does.

As Jerry Jeff Walker sang.... "Pissin' in the wind."

I think the MAA is still in process. It will take as long as it takes.

Most of this discussion is pure speculation based on inadequate information. As such I consider it entertainment.

It's not like anything posted on this board is going to make the decision any faster or any slower.

I didn't say anything about what stage of the process the MAA is in. I was discussing the total time till approval based on what little information the reported stats provide.

I agree with you that the inspections should come later in the overall process.

The question is, how long are the final stages?

Seriously faulty conclusions. But if that pleases you, go right on.

That could be. Or it could be that the size of the application is slowing the process down as they wade through that massive number of pages.

According to their statistics 66% of the national MAAs are taking longer than the statutory time frame. They don't say how much longer. And, size of the size of the MAA, the NWBO could be the one taking the longest amount of process time.

We just don't know and they aren't telling.

That backlog reduction number is for all classes of MAAs.
Our is in the much smaller subset and based on the number granted (3), it is a very small subset.

If I am getting this right, if 3 were grated and only 33% were within the statutory time frame that means there are 6 more being processed that are longer than the statutory time frame and NWBO is one of those 6. Actually that assumes the 3 were granted within the time frame. It could be that not all 3 were within the time frame which would suggest there are fewer in progress.

So, tell us what you really think. Lol.

For national MAA the AVERAGE was 208 clock on days. More interesting is the stat at the right side of the chart that say 33% were granted within the statutory time.

That tells me that there are a few (3) that were granted quickly. And some that took a lot longer.

So more than the statutory 210 days, plus any clock off time. Not really enough information to work with.
It would be nice if the gave the range of times.

That is some scary data.

Sorry. I don't operate in that rarified domain so I was unaware of that. Thanks.

In the case of Rett, the outcome.

Ummm. Mods CAN'T ban people. Only admin can do that.

Sounds to me like he learned from his mistakes. A good quality in management I think.

Part A is not placebo controlled, only Part B is.

We don't know the breakdown of subjects in each part. I agree that the number in Part B is going to be small no matter how it breaks down.

We shall see how it turns out.

Of course they can be stat sig. His point was that it isn't going to be large enough to impress the market.

I'm ok with that line of logic. I don't think that Anavex is interested in impressing the market with a P2 trial. That would be money spent on a low return effort. Especially considering how "the market" already views Anavex. Impressing "the market" is not likely to succeed even it it was a larger P2 trial.

IMHO, that same money would be more effectively spent on making the P3 trial larger, if there is one.

How do you assume that it won't be stat sig?

I'm not sure I understand your credibility argument.

It's a phase 2 trial. It won't be published in a paper, its function is safety and dose determination.
That information will be used to determine go / no go on phase 3 and what dose should be used for phase 3.

Phase 3 is where efficacy is demonstrated and credibility is established. The P value will establish credibility.

Multiple posts on a single screen, no ads to put up with. Search.

I hope that is the case. LP said that they were preparing to answer any RFIs in advance just in case. I expect that same level of preparation for the inspections. NWBO has an advantage with the inspections having already been inspected previously.

I don't think that is correct George.

The total trail number of participants is given as 40. Those subjects in phase A are not eligible to be in phase B.
So, the number of subjects in phase B has to be smaller than 40. My guess is it will be closer to 30.

It turns out that the MHRA doesn't grade on how long it takes to prepare and submit a MAA. This is not a college final that is timed.

The MHRA will determine the application worthiness based on its data and completeness.

Speed costs money and NWBO has been short of that for a long time.

Says the guy with 23 posts for the day at 4PM CDT.

Is there still a 30 post limit on the free posters?

This year the share price has been in the 3s twice and both the company and the shareholders survived.

The outcome of the EMA and FDA filings is what matters. Till then, the share price is interesting from a trading perspective, but from a long term perspective it is not that important.

If you think those filings will never come, then trade accordingly.

The same poster posting under several different aliases is pretty unlikely. Ihub is pretty good about catching that and booting those people.

Now, the same alias being used by several different people is much harder to catch.

He was booted from I hub. All of his posts, if there were others, were deleted.

You invest your money where you think it makes sense. I'll invest mine where I think it makes sense. So where are all these developmental biotech you talk about that provide the positive returns? I'd like to buy some of them also.

I assume you post on those boards also. Oh wait..... I just checked your posting history. Everything you post on is going down. Hmmm.

Keep flogging.

It's a developmental bio tech. These are always dependent on drug approval. The investing results will only be known when the agencies have their say.
Till then it is paper losses, or gains for those who trade during the process.

I haven't been in NWBO long compared to many that are here. That also means I haven't had the opportunity to do any trading of the stock to improve my cost basis. I hope that others here have been able to do so. Looking at the historical chart, there have been many opportunities to do that.

I have bought shares and expect a positive return. Maybe even a very large return.
We shall see how this turns out.

Hardly devastating. Mostly a rehash of the negative talking points that have been on the board for a long time.

It remains to be seen if his criticism of the small n of the AD trial is an issue for the EMA. Sure larger is better. That is not the question. The question is, does the EMA think the data on the n presented is good enough for approval.

The standard process with the EMA is pre submission meetings and Anavex has said that the EMA has seen data and was "encouraging" about submitting an MAA. That tells me that the EMA doesn't have a problem with the number of patients in the trial, so that issue is off the table.

As for most of the rest of the article, meh.