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.
Down by the river...
I didn't list all the reasons for filing in the UK first, just the ones you didn't discuss.
The UK MHRA is already familiar with DCvax-L and the production process. The production process has already been approved in the UK. The FDA would be starting from scratch.
The EMA process doesn't move as fast as you are projecting. Be aware that the timelines given by the EMA are in working days, not calendar days. So the usual time frame for EMA approval ranges from 391 to 460 days. The EMA does have an accelerated assessment process but that still is150 days plus clock stops with and average of 222 days.
The FDA is on average about 9 to 10 months unless it has fast track designation, then it is closer to 6 months. So if the MAA and the NDA are both submitted by EOY then the FDA approval would come first.
You seem to forget two important things.
The company is short of money.
The limited capacity to produce DCvax-L.
Other than that your logic makes sense.
It's green. Sheesh.
What you forgot is that Reg FD applies to material information.
What? You don't consider a cat 3 seasonal?
Sounds like a personal problem.
I guess we will see how things turn out.
I disagree with your outlook. For example, Anavex could announce a partnership at any time.
It doesn't look good for sparkly bicycles this Christmas.
Either way...So what. He can post whatever he wants as long as it's within the TOU. Just like you can post the stuff you like all the time.
Like your constant posting about Missling has to go had a minimal effect on the voting at the last AGM.
So far as I can tell, nothing posted on this board has any effect on the share price. I can say that I have learned a lot from many of the posters on this board, for which I say thank you.
No 503 errors for the last several hours.
Thanks Geeks.
As the Bible says.. The Geeks shall inherit the earth.
Or something like that.
You make a good point. I hope the NWBO shares you hold pay off handsomely for you and an annual subscription becomes a drop in your financial bucket.
I have to slap my hand sometimes to keep me from buying more NWBO than a reasonable allocation permits. Oh wait... I have already done that and I have the calluses on the top of my hand to prove it.
There is the paper, FDA filing, additional trial starts that are coming.
I can understand that. I find the cost on the annual subscription to be worth in reduced aggravation since I can see 50 posts on one page and don't have to deal with the ads. There is the index of posts page so you can see all the posts and the emoji ratings as a single line entry per post. Also being able to use the search function is helpful even if it is pretty rudimentary. The ability to PM is an added bonus.
I guess I'm fortunate that I can afford the indulgence.
I'm also getting the 503 error. It comes and goes. I can hit refresh and quickly get the error 3 or 4 times in a row and then the next several updates or message requests will be quite fast.
Some sort of DNS problem?
You haven't read what exwannabe posts or the bashers ?
I agree with you on that. What you stated is a particular circumstance. I was speaking in general terms.
And what you point out is what the Anavex lawyers have done.
A motion to dismiss can be filed at any point in a case. In this case it was filed at the beginning before any discovery was ordered. Because of the security law, that action stayed any possible discovery until the motion to dismiss has gone through the response and reply process.
Why wait? Because LP wants more than they were willing to pay for an unapproved treatment. After all, if you read this board the treatment is marginal at best. May be they are betting that NWBO will go BK and they can pick up the technology on the cheap.
The FDA doesn't tell BP what to research. The FDA can only act on the drugs presented to it.
Question for you, if BP starts presenting alternative drug approaches to the FDA does that mean the 70% funding is no longer corrupt?
117 million shares traded in one day out of the blue on, no news.
Discovery won't commence until the motion to dismiss is ruled upon. If the motion to dismiss is granted there will be no discovery.
The only one being fooled is you if you think one poster on a minor message board has any effect on the share price of Anavex.
Yeah. Leaks happen. Almost a guarantee, Just like that deal with Roswell Park leaked. Oh wait. That deal was two years in the making and NOTHING leaked out about it.
Your theory about any deals NWBO is working on with BP must leak out is weak at best and really just BS.
I have no doubt that there have been feelers from BP to NWBO. I suspect that management and the BPs are both waiting for approval. Management because approval gives it much more leverage. BP because they don't want to pay what management is asking until there is an approved drug to justify what management is demanding.
Actually that is not true. Missling reduce the communications remarkedly after the first class action law suit. Seems like learning to me.
You do realize how lame that is in the context of what the company is doing and where it is headed, right?
It would not have affected my life style back then either other than in a positive way if the $M club had held.
I have a larger position at a lower cost basis since then. Not massively lower or massively larger but improvements in both.
I think you are wrong.
You have a problem with them persevering for the last 15 years and getting paid for it?
Please explain what program you are referring to that would get it approved much faster?
There is AA, Rare disease to choose from.
Standard approval time frame is 9 to 10 months. AA is about 6 months.
Nonsense. The company has to file with the FDA first. Then and only then will the FDA look at the application. The FDA will consider that other countries have approved but will still look at the data. As I understand it, the FDA will consider the data provided as having been vetted, it will still require the data to demonstrate efficacy.
I am not suggesting that the data will not demonstrate efficacy. I am suggesting the FDA won't feel the pressure you suggest.
What a disingenuous post that ignores reality.
NWBO is a cash strapped company and has been for a long time.
NWBO chose to file in the country that has granted compassionate use for its treatment and has the most experience with the treatment. So yeah, they filed where they felt the likelihood of approval is the highest. That approval allows the company a revenue stream, a legitimization of its treatment MOA, and access to more funding at less than usurious rates. Approval in the UK would also match the production capacity with the demand as the company ramps up production capacity with EDEN.
Then application to the FDA makes sense, until then there is no point in getting FDA approval for a treatment that can't meet the demand. That would be business malpractice to get FDA approval
before the company has the resources to meet the expected demand.
But you knew all those things.
Indeed there was a lot of undue influence. Much of which came from the AD advocacy groups. The generous explanation is that they wanted something for AD patients even if it was minimally effective, it was better than nothing. The less generous explanation is those advocacy groups were supported by large donations from the companies trying to get their drugs approved so it was in the self interest of the advocacy groups to advocate for approval.
All in all, I see that as a political decision to satisfy the advocacy groups. The FDA had to know that the costs and minimal benefits would not see the drug be widely used. In fact the first one was withdrawn from the market place due to non acceptance in the market.
So the FDA threw a bone to the AD advocacy groups that had no meat on on it.
Somehow you seem to be focused on one poster that has an unrelenting positive view of Anavex. And yet you don't seem to have that same focus on the poster that has an unrelenting negative view of Anavex. Why is that?
It's like you think that one poster can actually make a difference on what the stock does or can have a significant influence on other posters.
I suggest you check your assumptions.
There was also genetic data to be sent to labs and evaluated. Gene expression and gene variants were also part of the other measures. Those things take time both to get back from the labs and to evaluate.
Most trials just use the standard measures, that are scale data, which is easily processed.
Yes it is.
The decision is based on the belief that Anavex will ultimately succeed. How ever it also provides enough time for an exit strategy if things look bad during that time frame. It will be at a loss of course, but as you have posted, sometime you make money and some times you lose money.
I still have the fundamental evaluation that Anavex has multiple shots on goal and it only needs to score once for there to be money to be made.
Some might call that WGT. Others might call that enlightened optimism. Either way, I have allocated money based on my evaluations of the situation.
All of my investments discussed on this board are out of my high risk trading account. If that account gets wiped completely out it would be really annoying. It would not affect my life style at all. If I make money in this account, it is all discretionary spending money.
Good luck to all that follow Anavex.
Sold a few shares and rolled that money into Jan 26 $10 options. My modeling shows that above a $14.73 SP the profit on the options is higher.
The article reaches people to create awareness of Anavex. That is a good thing. It doesn't have to be analysis by the best in the world to be helpful. If it was a slam job by AF would that make you happier?
My state's DMV is 90% funded by DL and vehicle registration fees. Does that mean that it is coopted by the driving public?
The FDA charges a user fee for services i.e. the costs of evaluating a drug application. The fee is paid up front. It is not contingent on approval.
It's not like BP can take their business elsewhere if they don't like the service or results from the FDA.
The FDA is the gateway to the US market which is one of the largest and most lucrative drug consuming markets in the world.
IMHO the argument that the FDA is corrupt because it charges user fees that make up 70% of its budget is bogus.