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Interesting, because every time I talked to the chef he was telling me how to order and what the delivery times would be.
That is what the RFI periods are for. If questions are raised by CHMP "wanting" the company has a time frame in which to respond to the issues raised. If the responses are not considered sufficient then sayonara. If the response satisfies the CHMP then the approval process resumes.
That is not my understanding of the way journals operate. They might take a look at a proposed paper and ok it for further review but in general a paper is submitted and then the journal sends it out to multiple reviewers. The reviewers can reject the paper out right, return it to the authors with comments and request changes, or accept the paper as is and recommend to the journal that it be published.
It is not uncommon for the requested changes, modification by the authors, and resubmission to go through several cycles before the reviewers are happy with the paper.
It is at the end of this process that the journal's editors make the decision to publish or not. As I understand it the journal's editors are kept informed of the progress of the paper.
Once a paper is accepted for publication, the journal editors will decide when it gets published. It could be the next issue or the paper could be held due to more important papers or even held for a themed issue that the paper fits in with.
Kewpie is just mayo with a tough of mustard. I was disappointed with it.
I picked up Jan 25 $5 options today for $1.35. I'm happy with those.
Wow. They sure are good at hiding all those naked shorts.
I hate to be the bearer of bad news. The percentage of shares short on NWBO is quite small compared to the OS count.
Unless there really is a huge amount of naked shorts, there just aren't enough short shares for a squeeze.
All I can say is you have your opinion on these things and I have mine.
Apparently you confused "clear that the treatment will be approved" with wait until the approval decision is posted. To me that means post RFI periods with positive feedback from MHRA. That would allow for the NICE filing in advance of the approval.
Yes Nice will decide whether the requested price from NWBO is cost effective or not. The MABS being a clear example of that. My statement still stands. " ... if they do approve it, the price will include a reasonable profit and amortization for development." NWBO will include those items in the price it submits to NICE. We can go into the details of the cost benefit analysis however there is the intangible of DCVax-l becoming the new SOC that shows real improvements over the existing SOC.
Are you suggesting that NICE is so clueless that when the cost of treatment drops by 50% or more they wouldn't be interested in renegotiation the reimbursement rate? I'm pretty sure that MHRA would let them know that EDEN has been approved and what that means for the availability of treatment and the associated costs.
Not following your logic.
No need to submit to NICE until it is clear that the treatment will be approved. Nice will look at reimbursement based on what the treatment costs are at the time of submission. There is no guarantee that EDEN will be approved or how long such approval might take, so NICE will deal with the reality in front of them.
NICE will either approve reimbursement on not, but if they do approve it, the price will include a reasonable profit and amortization for development.
NICE will be aware of the EDEN process and will expect the company to apply for reimbursement when that process is approved and comes online. No doubt the reimbursement rate will reflect the reduced costs of the EDEN process. That rate will still include amortization of the development costs and a reasonable profit.
If there is no way to make money getting in and out quickly I guess the way to play the company is to behave like an investor and invest on the long term prospects of the company.
Anathema to some. Good judgement to others.
It did for the 5th Dimension.🤑
Wow! You are my hero.
And yet you bought? How perplexing.
Is that you mike_dotcom?
Thanks for bringing that to the board.
A little more awareness of the company amongst the professionals.
Thank you for providing worst case scenario analysis. It's always good to see the worst case.
I don't think that is the way that things will go down, but we won't know till it happens.
Thanks for that information. 🙂
I know you believe the rapporteurs were being appointed in March, what evidence to you have to support that belief?
That dead matter has to be absorbed by the body at some point. How long does that take?
Yahoo uses closing price of the first trading day of the year it looks like.
I don't think it will take that long. Once approved and Eden comes on line, additional trials will be started and the primary measure will be tumor size reduction which happens fairly rapidly.
That is not what Yahoo chart shows. According to that chart AVXL is about even YTD.
That was three years ago. Maybe you should consider turning loose from that.
Because Ihub policy is to let the readers determine what is truth and what is nonsense.
A mod's job is to enforce the TOU and nothing more.
I would also point out that personal attacks are a violation of the TOU.
Gosh. Sounds like a crisis alright.
I feel your pain.
Apparently BS has superior anti-cancer efficacy.
Not on any board I moderate. I can see my ignores but no one else's.
So you are suggesting a buyout>>> A real possibility if the price is right.
That is the down side of being a mod. You really shouldn't put anyone on ignore. Which means you have to read all the id10ts.
The difference being that any amyloid reduction, and there seems to be some along with Tau, is secondary MOA, not primary as in the other drugs.
Specials and approved are very different categories.
For a start there will be much more awareness of the approved treatment.
You obviously haven't looked at the "supplements" market.
Sometimes BP pays big bucks for Phase 2 drug candidates, in the billions of $. There is no immediate payback there either and a lot higher risk than NWBO at this point.
It's called investing for the future. In the case of NWBO I think it will be called not wanting to be left behind. NWBO patents are worth a lot of money once the treatment is approved. I think those patents will make it more difficult for other companies to enter the DC space with any capacity.
Since an approval in the UK would allow patients from all over the world to seek treatment, I suspect there will be more than enough people that have the money to pay for the treatment to keep the folks at Sawston busy while Eden is being certified.
If $200,000 is what stood between me and a chance to survive GBM I'd willingly sell my house and move into a cheap apartment if that's what it took to have a chance at living.
Recycling at it's best.
You make several assumptions to support your assertions. The most obvious is there is no deal offered because there is no deal.
Has it occurred to you that maybe the company is willing to wait till after approval when it will have much more leverage in making a deal?
Then there was a recent placement that brought about $3 mil into the company. Why do you assume that other such deals can not be made as needed?
After all, the company has survived a very long time under exceptionally difficult circumstances, why would a few more months suddenly be a big issue? Management knows how to keep the company alive and moving forward.
Once approval is granted the company can immediately start getting revenues by license agreements. That would solve the reimbursement issue that you raise, assuming of course that it is a real issue.
The amount of dilution on a percentage basis is minor given the OS is 1.2billion shares. Compared to the value of making a deal post approval that amount of dilution is trivial.
Management keeps selling shares (not dumping) to fund the company as it nears approval, revenues, and access to much better funding terms.
The other choice is most likely BK.
As to the question of whether that is enough to suppress the share price, I'll let each person come to their own conclusion about that.
Yuk yuk.
Patience Grasshopper. 😉
I have much more faith in Anavex getting approved than I do in you ever posting something worthwhile.