1. Phase 2B trial of the obesity drug AOD 9604 -Three hundred patients to take part. Duration: Three months.
Patient screening is scheduled to start in September 2003 and the first patient is expected to commence treatment in October 2003.
2. From the FDA boss, mr McClellan:
“…. one key part of the FDA’s new medical innovation initiative is to try to facilitate the development of better treatments for obesity and diabetes. These are areas where we think regulatory pathways could be improved or better defined, and where we intend to give priority attention to potentially valuable new products.
3. Favourable toxicity draft reports Draft reports on 3 month toxicity studies in monkeys and rats have been received and are favourable. ___________________________________
Every man and his dog have applied to be enrolled but they only need 300 patients. Phase II trial to start in Oct. and duration is for 3 months only.
This is the last part I like: "3 months only".
If the results are good then most likely a partner will be approached to carry out the commercial arrangements, including Phase III.
As mentioned, the FDA is very interested in obesity and with the good relationship MBP has with the FDA, it is possible that FDA may grant a shortcut: Start commercialisation after Phase II and complete Phase III after.
I can't promise anything but there is a very good chance it will happen.
So, with the Cash in hand and an important Trial on their footstep, exciting times to come!
Gerry Please do your own research and you decide if and when to buy, hold or sell any stocks.
MBP Price at posting:
0.0¢ Sentiment: None Disclosure: Held