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Old 09-19-2010, 02:58 PM
soccertese soccertese is offline
Magnate
 
Join Date: Nov 2007
Posts: 2,531
15 yr Member
soccertese soccertese is offline
Magnate
 
Join Date: Nov 2007
Posts: 2,531
15 yr Member
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supposedly they will present results sept 28, got this off another message board but no link to verify.

phase3 depends on funding but phase2 results just came out. medtronic supplies the catheters for infusing the virus/gene mixture.

Under a manufacturing and development agreement, the Company and Medtronic, Inc. (“Medtronic”) have co-developed a new catheter infusion device to infuse the Company’s gene transfer product into the brain with respect to the treatment of Parkinson’s disease. (See “– Manufacturing”). The FDA reviewed and approved the use of this device in connection with the Company’s Phase 2 clinical trial for its Parkinson’s disease product under the Company’s investigational new drug application (“IND”). The use of such a catheter facilitates the delivery of the Company’s gene transfer treatment by neurosurgeons and simplifies the procedures for infusing the gene product into the brain. In order for the Company to market its products, Medtronic must obtain the FDA’s approval for the commercialization of such catheter infusion device, and the Company must obtain sufficient quantities of the catheter infusion device whether from Medtronic or another manufacturer. (See “Risk Factors”).

The Company is currently taking steps to move toward a pivotal trial for the treatment of Parkinson’s disease, and hopes to be in a position to file its protocol with the FDA in 2010 or 2011. The Company’s conduct of such a trial will require, among other things, approval by the FDA and adequate funding. Currently, the Company estimates that the pivotal trial could be completed in 2013 and the estimated total direct costs to reach that milestone are expected to be between $20 million and $40 million. (See “Risk Factors” and Item 7 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations”).

http://www.sec.gov/Archives/edgar/da...03249e10vk.htm

they are getting help looking for phase3 financing, doesn't mean they will get it or FDA will approve phase3.
http://phx.corporate-ir.net/phoenix....437&highlight=
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"Thanks for this!" says:
imark3000 (09-19-2010)