Ann: iPPS Demonstrates Multiple DMOAD Signals in Phase 2 Study, page-239

Relistening to the recent presentations :-

1. DMOAD will not slow the release of IPPS to market as it can be done within the existing Phase 3 framework (nor does it replace the Primary Endpoints of Pain and Function).
2. Future requirements to support a DMOAD indication are not yet known as these are dependent on the FDA discussions in the 2nd Half of the year which Im guessing they have been told require the Dog Study Results (due in the current quarter (which are encouraging "Pauls words") to show duration. I am guessing but I would say the FDA will want to see the 1 year 008 results as well. Only then will we know if DMOAD is even on the table. FDA may say we want a bigger 008 (which would not be possbile without delaying registration).
3. TGA is dependent on EMA which to some extent is dependent on FDA.
4. There is clearly something in the DMOAD program that is pivital to TGA licensing discussions (which I vaguely recall was the TGA want to see more than just pain and function to approve early .. "My words and I am probably wrong here"). Remember TGA is one shot so we may be wasting alot of effort for nothing if we cant get it accross the line.

Either way I dont think we will be seeing much progress for the rest of the year due to waiting for the info with the exception of an early MPS deal (which Im not really expecting without some compelling data).

Strap yourselves in for an unpleasant ride ( I hope Im totally wrong BTW)

The "Dark" Pool