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.
I think you mean " a more brainer." 😉
As I understand it the average drug development time to approval is about 10 years.
I do agree with you that some of the data should have been released by now. As for the discussions about AA and BTD weren't those here on the board? I don't recall the company discussing those things.
We all wish things had progressed faster.
It is my opinion that the MAA has been filed based on the date of the centralized procedure PR and conversations with IR. If I am wrong on that it should be filed soon.
You are not the only one that feels that this has taken longer than expected. I join you in that. Alas, hindsight is not helpful in this case.
Let's start with your 9 year horizon. Does that assume that Anavex should have had a drug on the market 9 years ago or submitted to the FDA 9 years ago? Is that the baseline you are using for your 9 years starting point?
I don't win every argument or even most of them. I do bring facts and reasonable assumptions to the discussion and I try to back up my opinions with data to support them.
Others not so much.
So yeah, I think your 9 year premise is a straw man. And I'm not using ad hominem attacks. I just disagree with your statement.
Your math is speculative. It assumes immaculate trading is the norm.
Sure, If I had sold at $24.582, the close of that intraday high you are so proud of, I would have more money in my trading account. Of course I would have had to not buy back in for a month or more to realize any significant position increase.
Your math isn't wrong, your premise is wrong.
I and many others are not in Anavex for the short term gain, I'm in it for the long term gain.
So, let's revisit this discussion in the future when it counts.
No, it doesn't matter.
That is history.
What matters it what is coming. And, I like what I see coming.
Did you notice that last Friday AVXL closed at $5.48?
Seems like a pretty good week to me. The sort of thing that suggests positive expectations.
It was adown day. Did you happen to notice how much AVXL is up for the week?
Or, is that sort of context not in your interest?
If only ...
If a post is deleted as OT then it can be appealed.
As I Mod I review all posts that are deleted and those that are restored to make sure that I am current on the TOU rule interpretation.
Trial size is determined by a number of different factors. The desired size may be reduced for rare diseases because of smaller population availability as you suggest.
In general a trial size is chosen to provide enough power (n) to demonstrate the expected effect to statistical significance. The smaller the expected effect the larger the n required to demonstrate it.
There are other considerations such as having enough people to allow for sub groups to be analyzed. The FDA likes to see a diversity of the population when possible so that can increase the size of the trial.
Also the type and strength of the measured end points plays a roll in trial size. If the measures are not very sensitive such as ADL then the n must be increased to capture any effect.
The addition of biomarkers that are clear measures of effect can have the effect of reducing the n size to show efficacy.
So there are a lot of considerations involved in choosing an n for a trial.
More importantly, what awareness that would be created would be dissipated by the time that Anavex has a drug on the market.
If the purpose is to get people into the stock, the technical term for that is pumping.
Save those advertising Dollars till after there is an approval.
You're still here. Hmmmm.
Short report is due out tomorrow after the close.
Thinking big and having the money to do big are not the same thing.
My argument was based on the financial aspects of the situation not the regulatory aspects.
The company has very limited financial resources so it has to apply funds very carefully. If the company had $100 mil available I'd be willing to bet there would a number of things being pursued that are not currently being worked on.
I think you are incorrect on the way that timeline works.
My opinion on that is filing an MAA is not material. It has no immediate financial consequences. The results of an MAA filing would be considered material.
I didn't know the Commodore PET had a browser. 🤓
The MAA should have been submitted by now and the company has chosen not to PR that. Given the history of the company on PRing dealings with regulators and the regulation process I doubt that they will.
Your theory about taking a chance and a possible no answer would be a setback for sure. Just like Rett was a setback. It is an unavoidable risk in the drug development process.
At some point the company has to apply for drug approval. I do expect that we will get a PR when the NDA is filed with the FDA. I wonder if Anavex will wait for the initial CHMP evaluation of the MAA to see what, if any, questions the CHMP has so they can be addressed in the NDA prior to filing.
NWBO would not have filed the MAA if they thought that Sawston was not an acceptable manufacturing facility. The MAA can't be approved if there is no mfg. facility for the MHRA to inspect.
Given that the EDEN units are not yet in production it makes no sense to first apply in the US and get approved with the Sawston since as you point out the production capability is limited. Why get approved in a market that the company can not supply?
The UK is quite familiar with the NWBO facility, the trials, and the present usage of the treatment. So that makes applying in the UK the obvious choice. The demand for treatments will be much smaller in the UK which will more closely match the production capacity till the EDEN process is tested and approved.
Once DCVax-L is approved and there is some money available to the company, EDEN work should move along rapidly and the company can start preparing the FDA NDA. It might make sense to apply to the FDA using the Sawston facility to obtain approval while EDEN is getting built and tested. That would save a considerable amount of time.
My rational for that is that getting approval using the Sawston facility gets the BLA approval done while waiting on EDEN to come on line. I think getting approval for a new production process for an already approved biologic will be faster and easier than having all of that in one package.
Your thoughts?
I'm not sure I understand why you think that Sawston would not be an acceptable production facility. If it meets GMP standards then it should be acceptable. The fact that it is a manual procedure shouldn't be an issue if the process is documented, tested, and meets GMP standards.
I thought every one knew.... 42.
It only has to be Pr'd if it is material information.
There appear to be two definitions of what material information is. There is the popular definition which includes a lot of information and the SEC definition which is much narrower.
Unless the information has direct and significant financial impact the SEC doesn't consider the information material with the exception of a change in officers or directors.
The manufacturing facilities inspections.
LP said they had not been scheduled yet a few weeks ago. They are part of the approval process.
TTsr. How do you get past the inspections requirement that the CEO had not yet taken place?
Some posters have complained about Anavex not getting its name and drug publicized. That seems to me to be a false narrative and this is another fine example of why that is a bogus complaint.
Do you have some trouble understanding the word possible?
It doesn't really matter what our opinions are on the approval possibilities. That decision is in the hands of the regulators.
It only matters to an individual investor in how they choose to position their portfolio.
More likely it is a sign of long term investment thinking.
Because it has not yet been approved and it is a novel approach to CNS disease. Oh yeah, there is a large short position.
What public serving vigilante you are.
The few that show up on the AVXL board talking about NWBO are not nearly as annoying as you are here on the NWBO board.
It appears that you believe one bad turn deserves another.
The Cloudstrike screwup had a major effect on the market.
It is an Open Label Extension to the primary trial.
Since it is open label and the population in the OLE trial is self selected the RA don't give the trial much value in terms of proving efficacy.
What they do value is the safety aspect of the longer exposure to the drug.
Whether the company has seen the data during the OLE or not until the end of the OLE makes little difference. The data doesn't change either way.
That is a good question.
I'd guess that the subjects on placebo will have to go through the same titration process as the original trial subjects to get to their max dose.
Your appeal to an anonymous internet authority (you) is not persuasive.
I value the MHRA'a opinion more. We will see what it has to say.
Their approach has taken a very long time and has cost a lot of money to develop and test. So those are sunk costs. It would seem that obtaining a return on those sunk costs would be the wise thing to do.
You haven't named any other approaches that you deem to be better.
Your ego is overriding your judgement.
As you know, bio techs are risky and can generate huge returns and great losses.
NWBO has an application for biologic approval in with MHRA. Are you saying that NWBO is going to be a bad business if their MAA is approved? How do you justify that opinion? Do tell.
I almost believe that.
Thanks for that info George.
Not to piss on anybody's post toasties, but if DCVax-L was the be all end all, the survival rate would well over 90%.
DCVax-L represents a major step forward in Glioblastoma and other tissue cancers for sure.
The fact that it works better with poly iclc tells us that this is not the end of the story and that there are other pieces to the puzzle to be discovered.
Having said all that, I wish I owned more shares than I do.
I hope the MHRA renders it decision soon and you folks that have the hundreds of thousands of shares, and have been in NWBO through the very long trip it has been, make the big bucks.
Given the large number of open $5 calls that expire on Friday, I think a close on Friday of $5 is good bet.