chart update, page-102

Playez, The board should be doing whatever is necessary to eleviate any misconceptions about the coy/science.

You have an interesting sentiment considering your position.


What has always bothered me was the sudden change in direction, focussing on one Oxy patch to as far as they could go and perhaps strike a deal at the end, to now the build up of a pain portfolio with no real defined Ph 1/2/3 studies of each.

The large cap raise @ 14c per share I put my hand in my pocket like most of you was clearly defined for OxyC. Nothing more.

Quoted from Announcement 21/10/2011:
"The capital raised is expected to fund our TPM/oxycodone clinical trials which are scheduled to start next month. We expect to lodge documents for FDA registration in 2013

This is what I signed up for; not Ph1 safety studies for Oxy A-Z and what other pain drug they can throw into the mix. Instead of spinning wheels, get 1 Oxy through to the end and then worry about a family. You would be surprised how easy the 2nd Oxy and so one would be will with Pharm knocking on your door throwing money at you when you have successfully demostrated 1 Oxy pain patch. No one is going to look at you when you are still pottering about in Pre-clinical or Ph1 trails regardless of how many you have in the pipeline.

Most of you seemed rather excited to hear of a pain portfolio, but who the hell is going to keep funding these, with no real commercialisation of any of these for the next x years.

The change in strategy was not only sudden, but the company did not clearly indicate this change in strategy and the reasons for it. So why was the committment of seeing Oxy C through Ph3 changed? Were we ever informed of this officially (i have a short memory these days)?


From the December 2011 newletter:
"The initial trial will characterise the pharmacokinetic dose profile of the new patch on healthy participants from both single and repeated applications. This data is required for our planned submission to the FDA, and forms a vital component of the product dossier. The preliminary trial will be conducted on 65 subjects and will continue through the first quarter of 2012.
The results of these trials will be submitted to the FDA next year as part of an IND application in order to gain approval to conduct the late phase trials during the second half of next year.
At this stage our pain advisory board recommends that we go
straight from the initial trials to a Phase 3, leaving out a Phase 2 altogether.

This is made possible by the 505(b)(2) application route, which is specifically designed to short cut the clinical and review process for drugs that the FDA has previously approved."


No Ph2...originally required.
Was the advisory board sacked?
Were we informed officially that Ph2 was now required and the reasons for it considering our appointed advisory board did not think it was necessary.

What has the company actually achieved in its core project - the pain patch apart from addressing a crystallisation issue?

I know I am covering old bases here, but what the hell....
a piece of the puzzle is missing.


SUDs