21 october 2011 - the arrival of phosphagenics, page-22

Honestly KC, if the multi-dosing trial can reproduce what the single dose trial did over the extended period than there isn't much risk.
The only points of difference I am aware of is the transition period and the length of administration.
The desired blood concentration levels are achieved by applying precise mathematical formulas to the mechanics of the patch to ensure that therapeutic levels are achieved and maintained and released at the appropriate rate. These formulas and the protective mechanisms of the skin are also used to minimise the impact of simultaneous multi-patch application and abuse, a massive benefit of trans-dermal delivery over tablets.
The current tweaking is necessary to ensure that the above outcomes are achieved perfectly.
The extended length of administration does not offer any mechanical issues in my opinion. Clearance rates have already been shown for single patch application. It will probably be re-inforced for sustained delivery.
Reproducing steady therapeutic blood concentration levels over the extended period will complete the data.
There are really not a lot of hoops to jump through anymore.
Once this dress rehearsal is complete the question, which I have posed before, will be, what is left to test in the phase III that has not already been tested on a smaller scale.
Once the multi-dose trial is complete, I will pose this question to Esra and share the answer with you.
In short, there may be some aspects of the patch that pose a risk. I can't think of any. To reinforce this, let me say this. If there was an obvious risk that could surface, Esra and the team would not only be aware of it, but have already addressed it. They are ticking every box possible. We have some very very clever people steering the ship.