PG, actually the uptick rule was done away with in 2007 while Bush was in the White House. Modified versions are still used in larger markets around the world. Another version was started in the US in 2010 as follows."Adoption of Alternative Uptick Rule[
On February 24, 2010 the SEC adopted the alternative uptick rule. The new rule does not apply to all securities. It is triggered when a security's price decreases by 10% or more from the previous day's closing price and is effective until the close of the next day."
Burn boys, burn!
I too think everyone should follow me and be rewarded a gift of a lifetime! GALE will be the bio to have in your portfolio. Let's go GALE!
Hey screen the shorts are in too deep and they know it. Fast track for neuvax and orphan drug status for GALE 301/302. In a few days the lawsuits will be gone and data will be presented for the present trial. Next up will be the Roche Herceptin/Neuvax combo trials which are not blinded and data expected in December. I'm glad I'm not short. GLTA
At what price GALE SHOULD be trading and what it WILL trade on Monday are two completely different things. $5 will not happen on 6/13/16!
Gene, this is exactly what I said in an earlier post. The original designation was only for GALE 301 and 301/302 was added later and needed to be confirmed. Everybody gets their panties in a wad for no reason. This is huge news though. This will save Galena $$$ and get it to market sooner! I couldn't be happier! I first saw the news in Europe at 6:05AM ET yesterday and the stock rose in Germany a few minutes after that. Now on to 401, the signing off the lawsuits and NeuVax Present data!
Captdanger, I think since it is two Orphan Drug Designations 301/302, this is why Galena was slow to get out a PR.
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.
A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.
Generic Name: folate binding protein peptide: Glu-Ile-Trp-Thr-His-Ser-Tyr-Lys-Val
Trade Name: N/A
Date Designated: 06/08/2016
Orphan Designation: Treatment (including prevention of recurrence) of ovarian cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date: N/A
Approved Labeled Indication:
Exclusivity End Date: N/A
Sponsor: Galena Biopharma, Inc.
Crow Canyon Place
San Ramon, California 94583
There is a CC at the My-GALE website at 4:15. Has nothing to do with the company. Wake up people!!
Lin go to the website of this so called lawfirm and see the number of PR's they have put out with exactly the same wording! What a joke!!
Vice President Joe Biden to Speak at ASCO16
In a special session on Monday afternoon, June 6, Vice President Joe Biden will deliver remarks on the Cancer Moonshot Initiative to accelerate cancer research, prevention, treatment, and care.