The FDA granted orphan drug designation for Firdapse™ on November 12, 2009. Orphan drugs in the U.S. are granted a seven-year period of marketing exclusivity from the date of drug approval and, if Catalyst is the first to obtain approval of the product in the U.S., it expects to receive seven year marketing exclusivity for Firdapse™ for LEMS.
In addition, no drug product containing amifampridine for any indication has been approved by the FDA. Therefore, Catalyst’s amifampridine, if it is the first to obtain approval of the product in the U.S., will also be eligible for five-year new chemical entity exclusivity, which provides a five-year period of marketing exclusivity for all indications.
There is a pending method of use patent that, if issued, will protect Firdapse™ until February 2027, which includes five years of patent term extension that is expected under the Patent Term Restoration Act. Catalyst may also pursue other patents in order to seek to protect the exclusivity of the drug.
I'm sure Andre is just taking a break from the board. I'm probably buying CPRX tomorrow if it dips due to the slight delay & continue to watch ATRS's trading.
LPCN was selling for $8.00 in mid-April & did a secondary at the end of April @ $6.50. The stock closed today at $7.50 so it takes a few weeks to regain the higher levels.
Something is screwy with this. I doubt it ends up with an additional 70 individuals on drug for 6 months. Its either going to be an additional 500 patients on drug for a year or the FDA will drop the requirement of 70 patients for 6 months.
I don't think anything is gained by making ATRS run a trial for 6 months on a small group. You need a larger group or none at all.
How many posts did he make about the Population councils work with ATRS on female & male contraceptives?
I'm saying no company is going to partner with ATRS or Medac for a package which includes a biologic injector & methotrexate injector.
This is just speculation. Amazing investors continue to fall for this. Tell me why a company would use ATRS instead of Medac?
The FDA notified ATRS of this 5 months ago . Why didn't they just go ahead & start a new trial on 100 individuals instead of waiting for the FDA to approve a new plan? Its possible they're trying to get the FDA to change their mind on the need for data on the additional 70 individuals.
Exposing 70 more individuals to QST for 6 months shows how stupid the FDA is.
Pine, the market thought Otrexup was a $200 million drug & now the reality that it may be a $50 million a year drug requires a revaluation. The market also questions whether any combination product will succeed. Management has previously stated that generic gels were the biggest threat to a successful launch.
Sorry, I had to work today so I couldn't add to the discussion. I'll read the CC transcript later but I'm sure its the usual company line that things are great.
I think it has to do with how investors feel mislead by the company & some investors.
A recent example is a post on Sumatriptan. "From the web site below - you will see this statement
about Sumatriptan to treat migraine: I assume it is valid, but wouldn't swear to it.
From the NovaDel Pharma Web site (a N. J. company developing a Sumatriptan spray for migraine) comes this quote: "With more than $1.2 billion in annual sales, sumatriptan is the leading migraine remedy".
So this is a sizable market and we have a 50 / 50 split with TEVA."
So a well respected poster gives information on the general market which sounds huge but why not supply information on the direct competitor in the market.
Zogenix sold Sumavel DosePro (Sumatriptan injector) to ENDP in April/2014 for $85 million plus up to $20 million in milestones . The drug does about $40 million in annual sales. ATRS investors should be using this as the comparator instead of the entire market. So if we used this as a way to value how much ATRS's injector is worth.
Zogenix sold 100% rights for $100 million so I'd guess ATRS's rights might be worth $25 million.
How much will the TEVA/ATRS Sumatriptan injector add to ATRS's revenues on a yearly basis? If the current market is $40 million & then its split equally with TEVA equals $20 million. ATRS receives half the net profits on sales so that might be $7.5 - $5 million a year which is quite a bit different from the $1.2 billion market.
I think someone has hacked your account. I got a important message from your account & when I clicked on the link my security programs blocked the message. I think its a virus.