Ann: FDA meeting provides guidance for TPM/Oxymorphone patch, page-17

Yes to all. My point about safety is it needs to be the highlight and sold to the FDA that way, particularly in this case. The FDA don't want to add complicatinting factors to a drug that already has massive concern about addiction. The strategy used by CUV (not held) to developing its product is one example. Like TMP the CUV product has multiple applications but they have had a single focus on bring one drug to market. They started with the EU first and gained the right investors ex market. The CEO when asked said the biggest lesson learnt from the EU application process is to make sure enough safety testing is done prior to the application process to convince approval authorities like the FDA that safety will not be a concern. CUV are debt free, have income from sale in the EU and have an application currently with the FDA. I suspect RM is knocking on doors now looking for the right US based investor.