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New CEO and Board member
The new CEO and Board member are clearly quality people and provide new competencies to the company. These two additions are material positives.
Trading
Very hard to buy - the bid moves up and over any limit placed. If the company could put out significant good news that would spur buying in bulk, there would be a significant move.
Fast track (2)
They could file on the data released in January. If turned down they could file again after confirmatory trial.
Fast track
Thank you for link to the Nobel conference company presentation. Alkon did mention fast track status. Fast track is for drugs showing promise in treating serious disease, which address an unmet medical need.
Serious: the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
Unmet: the drug must be developed as a treatment or preventative measure for a disease that does not have a current therapy
Bryostatin would seem to qualify on both prongs! It would be a big deal in terms of public perception.
What Neurotrope would get -
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
Accelerated Approval or priority review if the requisite criteria are met. A fast track application is automatically considered for both of these designations.
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Thank you very much.
Fast Track, Breakthrough, Accelerated approval
Below is a blurb from the FDA website about breakthrough status. Would Neurotrope qualify? Also, can anyone help me understand which of Fast Track, Breakthrough and Accelerated Approval Neurotrope could qualify for and how significant they would be? Thx
On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation. A breakthrough therapy is a drug:
intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Thank you for this, appreciated.
Really good data. Why did it take so long to release?
Anyway, good data
Good news
Much better than I had expected. Farlow and Perry are the real deal and permitted themselves to be quoted. They will be first line therapy in moderate to severe Alzheimers - yes IV for now, but a depot or other delivery will be developed. Even if the drug is $100 million per year, the stock is undervalued. It will sell way more than $100 million a year.
Keynote
The organizers would only pick Neurotrope to give the keynote if the presentation was positive.
The only question is how positive.
Keynote means good data
The data must be positive if the presentation is keynoted
Perry as director is important too, so now new ceo, and two new directors. This constitutes real change.
New CEO and director
Impressive resume.
Annual meeting
Is anyone going?
Runcoach, thanks again -
http://www.ebdgroup.com/bts/core/presenting-companies.php
they are presenting. Hopefully have something to say.
Runncoach, thanks for finding.
I am surprised how low it is too.
He wouldn't be listed in the proxy unless he had accepted the board's nomination. The shareholders then vote to elect him or not. I think they will elect him.
Thanks for the heads up. I just read his resume in the proxy. Perry is the real thing.
Thank you
Rodman conference
It must have been a good presentation at the conference. Did anyone here go to it? Did they say anything new?
Trial results
I thought they were pretty good trial results actually. Given the markets; reaction I'm in the minority.
Upcoming event?
Is there any upcoming event or milestone? Company seems in limbo.
Volatile! on low volume. Any news good or bad will be a slingshot up or down.
Institutional holders up, to 12+% as of June 30. Stifel and Cannell are intelligent.
What is their next news they can release? I am looking forward to the earnings call. The balance sheet is kind of meaningless, they should have about 20 million and no debt. Can they talk about anything else? I thought the london data was good and hope they talk about it in detail.
Quarterly call
When does neurotrope have to do a call by? Maybe they will release the 17 week data then and talk about what the plan going forward is.
Thank you for posting this.
A company called Aegis evidently wrote about Neurotrope? Has anyone read it and can report the conclusions?
There is a clear signal. New mechanism of action, so accretive hopefully to memantine and aricept. They should have an approvable drug.