Dew
YM is developing AeroLEF for the treatment of moderate to severe acute pain<.
Is AeroLEF still a bona fide development program?
(a) I don't know anything about it and AM a poor source
of information.
However - this popped up in google --
(b) Google A says this --
YM BioSciences Provides Update on AeroLEF(TM) Clinical Development Program
Posted on: Thursday, 17 January 2008, 03:00 CST
MISSISSAUGA, ON, Jan. 17 /PRNewswire-FirstCall/ -- YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide,
today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the Company that the Phase II Acute Pain Study (AP5) of AeroLEF(TM) for which FDA clearance was announced on June 27, 2007, upon re-review of data from the IND submission, has been placed on clinical hold.
The FDA has requested additional safety information on specific patients in previous clinical studies. The additional requested data is limited to a small group of patients that experienced oxygen desaturation, a class effect of opioids including fentanyl.
The Company will conduct a subgroup analysis on these patients. To date, no patients have been dosed in the US AP5 study and there are no other clinical trials involving AeroLEF(TM) currently ongoing.
redorbit.com
(c) Google B says this --
YM BioSciences (YM.TO) Announces FDA Lifts Clinical Hold on AEROLEF(R) and Clearance of Phase 2 Trial
6/20/2008
biospace.com
(d) Google C says this --
Ym Biosciences Reports Fiscal Year End 2009 Operational and Financial Results
Friday, September 25, 2009 7:53 AM
Costs associated with development activities for AeroLEF(TM) were $1.7 million for the fiscal year ended June 30, 2009 compared to $2.0 million for the previous year. Costs associated with development activities for AeroLEF(TM) were $0.2 million for the fourth quarter of fiscal 2009, compared to $0.4 million the previous year.
The decrease was primarily due to the shift from clinical activity in fiscal 2008, to new marketing and out-licensing initiatives, as well as clarifying our regulatory position in Europe, in fiscal 2009.
NOTE - I am confused by the above - can't find a Phase 3
anyplace ...
So are they gonna partner it out ....?
regards
John |
