Seelos Therapeutics Inc (SEEL)

[OldtimeramI]

If Apricus has an improved formulation to present in the resubmission package, is the FDA still obligated to act within 6 months?

I think we can agree that the only NDA submission to the FDA so far was many years ago -- so any new data supporting a 7 day shelf life has not yet been submitted.

Bryce

I don't think there is formulation difference between Canada's version and Europe's version. I remember hearing this in one of the CC's years ago and just found information that relates to your questions.

One thing though, the delivery device has been upgraded / changed. So your end question might still apply to that aspect. If not, Vitaros would possibly be approved by the FDA with a failed delivery device.

Based on Richard Pascoe's answer to how Health Canada is more stringent versus the European regulatory agencies when it comes to product specification and how it relates to shelf life. I think the question would be: How does the FDA compare to Health Canada in this respect? This in respect to shelf life.

I am posting the CC where this information can be reviewed.

Jason N. Butler - JMP Securities LLC, Research Division

Okay, great. And then just on Abbott and Vitaros in Canada, you said there was something specific about the formulation in Canada Abbott were working on. Can you maybe just give us a little bit of color about that? Or, if not, at least give us some color why that is not applicable in Europe?


Richard W. Pascoe

Certainly. First of all, there's not a difference in formulation, necessarily. The -- each country's regulatory authorities when they approve a product such as ours will set certain specifications and limits on manufacturing. And just to sort of oversimplify it, in this case, when the specifications for active ingredient or inactive ingredients are set on a very narrow range or the limits, in particular, the lower limits are set at a lower level that is potential higher than they might be somewhere in some other country, that relates directly to the amount of shelf life one can achieve with the product.


So in Canada, their specifications are much more stringent than they are in other territories, such as Europe. And I think just to maybe put it into perspective, when you compare the specifications for the Canadian product to the specifications for the European product, you are able to achieve, roughly, a doubling in shelf life from what is available in Canada to what will be available in Europe. So this is a specification issue that Abbott is working with or working through. They're working with their contract manufacturing partner, and they continue to be focused on getting the product into the market as soon as possible. But they are also very cognizant and aware of the fact that they need to launch the product with confidence. And that's what they're working through right now.


http://seekingalpha.com/article/1424051-apricus-biosciences-management-discusses-q1-2013-results-earnings-call-transcript?part=single