Hiya, Orphan Drug Status to my knowledge has not been referred...

Hiya, Orphan Drug Status to my knowledge has not been referred to in any PRR release since last november in the 2009 AGM Presentation under the subheading "FDA Approval Timeline"

Achievements to date...(part only)



US FDA pre-Investigational New Drug Application (preIND)
meeting concluded October 2008
A PreIND meeting is a key milestone in FDA approval process

IND application for CVac submitted July 2009

FDA approval to begin Phase IIb clinical trial granted Aug 2009

Upcoming...
Multicentre Phase IIb clinical trial to commence early 2010
Clinical trial to be conducted on total of 60 patients
Orphan Drug Designation for CVac ovarian cancer treatment
Allows the FDA to expedite the final drug review approval process

It was also mentioned in the Investor Presentation held back in august under the same heading. Dcheckers noted in his excellent summation of that same meeting and welcome to new investors (post 4420222) that ODS approval was expected after granting of the IND.

As the phase 11B trials were to have originally commenced in late 2009, the expectation of obtaining ODS in approx 6 months presumably has slipped also. The FDA timeline suggests it won't happen until after these trials are "conducted" quite aside from the IND approval scenario.

I am thinking that any ODS announcement won't be imminent or am I misreading this?

Any thoughts?

cheers
billdah


http://www.asx.com.au/asxpdf/20091130/pdf/31mf8y2wxvc642.pdf