Generic Name: 1-(4-benzhydrylpiperazin-1-yl)-3,3-diphenylpropan-1-one
Trade Name: n/a
Date Designated: 09-26-2013
Orphan Designation: Management of postherpetic neuralgia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Zalicus Pharmaceuticals Ltd.
245 First Street
Cambridge, MA 02142
The sponsor address listed is the last reported by the sponsor to OOPD.
Sentiment: Strong Buy
It's definitely good news. How good? I don't know. I'm wondering why the FDA would give it some kind of orphan status before the drug is approved. One could take a leap to infer that the FDA likely wouldn't have done that if it was unlikely that they'd approve the drug - so... I'm feeling pretty optimistic right now. Just shy of giggling like a school girl. I'm definitely talking to my microbiologist friend tonight to see if he thinks high pitched giggling would be appropro.
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.
If What's Approved? The Drug?
NO, they have to go through clinical trials.
Orphan Status...This was pretty much expected.
Will we see $1.00 soon?
Of course we will; they want to stay on the NASD so they will announce a reverse split any day now. They will have to...the shorts live to destroy a companies reputation and they would not allow this to trade over a buck for 10 consecutive days.
ZLCS will have to do this by Oct. 8th for sure and I expect the news any day. The question is what the ratio will be and if the shorts attack it afterwards.
the drug is not approved by the FDA (the trials have to happen first). it simply received orphan drug status on the molecule. i'm long on this, but orphan molecule can still not be approved overall by the FDA.