Extract: "The principle of AOD9604, already proven in animal studies, is to mimic the natural fat reducing properties of human growth hormone without producing any effects on blood sugar control or growth. In the 10 mg dose group, the overall weight loss was 1.0 kg compared to 0.4 kg in the placebo group, and in the 20 older volunteers the weight loss was 0.8 kg compared to a weight gain of 0.1 kg in the placebo group". ______________________________ There will be an interval between the end of Phase II and the start of Phase III:
"Phase 3, the final step in the clinical trial process, is expected to require about 1500 patients treated for up to two years, and in tandem there is a requirement for manufacturing plant construction to meet the expected worldwide market demand on obtaining marketing approval.
It is common practice for biotech companies such as Metabolic to negotiate an exclusive marketing and distribution deal with a major pharmaceutical company that pays for these more expensive stages, in return for upfront and milestone payments together with royalties on sales".
So, there could be some negotiations between MBP and a big Pharma immediately after Phase II is completed:
"Metabolic expects to follow the partnering path in some form, and will continue to engage in discussions with several potential partners over the next year.
The Company’s policy is to assess partnering opportunities on the basis of the maximum long-term value to be gained by shareholders, the importance of exercising control over the further development of projects and the practicalities of further self-financing.
Joint venture deal structures which involve cost sharing with the partner in exchange for sharing of the worldwide marketing rights are of particular interest to the Company". __________________________________
This is the interesting part:
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". ---------- It is possible that MBP could ask for Accelerated Approval from the FDA immediately after completion of Phase II: FAST TRACK, PRIORITY REVIEW AND ACCELERATED APPROVAL: http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm
See what happens,
Gerry
MBP Price at posting:
0.0¢ Sentiment: None Disclosure: Held
