shareholder update, page-124

ahe8,

505(b)(2)

What has been said on this subject in the post below from pigofsteel is correct.

having a TGA background doesnt give rise to the knowldege about the subject to which you have posted, which is why i immedialtey asked you have you done any TD applications, because without this intimate knowledge you are providing commentary on a feild you know little about

So the answer is, if you are taking a drug through the skin that has not been taken through the skin before, even a 505b application will still take 5 years

Now given that the OBJ device is still not out of in vitro, you can add another year on that

What all posters and reasers must know is, they have not yet been able to get the device out of in vitro, so the risk is becoming higher not lower with the 3 m testing

Each pass, in an area of the testing lowers the risk profile of the drug or device commensurate to the level of testing passed, and at this point in the rsik asscoiated with the obj device is still 100% until it passes in vitro, at which time the risk will drop to say 90% chance of failure

In vitro is the first level of testing, if it does not get out of there this year you will still have 5 years after that

Many drugs fail to pass Phase 111 and do not get FDA approval, which means all of the years and 10's of millions of dollars just dissapear down the money pit of Pharma

I hope this helps