Biofreaks who have posted commentary elsewhere are welcome to crosspost it here. I've learned not to do this without at least asking. In the mean time I have a couple of questions for said biofreaks who probably have the answers off of the top of their heads . . .
Uno: Was Astellas responsible for the NDA in some way? The terms of their amendment to the agreement announced today seem to imply that they are accepting responsibility for the botched database. Am I reading that wrong?
Here's the PR:
>>VANCOUVER, July 10 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced amendments to its co-development agreement with Astellas Pharma US, Inc., related to the planned re-submission of the New Drug Application (NDA) for RSD1235 (iv), an investigational new drug for acute conversion of atrial fibrillation.
Under terms of the amended agreement, Astellas has agreed to fund 100% of the costs associated with re-submission of the NDA, including engagement of any external consultants. Astellas has also agreed to modify the timing of the US$10 million NDA milestone, which will now be payable on the date of re-submission. Prior to this amendment, the milestone was conditional on acceptance of the NDA for review.
"This action by our partner Astellas is a clear demonstration of their confidence in the RSD1235 (iv) program," said Bob Rieder, Chief Executive Officer of Cardiome. "The integrity and commitment embodied in this Astellas action demonstrates again that they are an outstanding partner company."
In October 2003, Cardiome granted Astellas' predecessor Fujisawa Healthcare, Inc. an exclusive license to develop and commercialize the intravenous formulation of RSD1235 in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of atrial fibrillation.<<
Dos: Any hangover from shady Canadian stock hustlers from the Nortran Resources days (aside from a sizeable share count), or is that concern all gone? I'm not saying shady stock hustlers were even involved at all, but it's an easy assumption to make.
TIA & Cheers, Tuck |
