Maybe someone with a bit more experience in this area can provide some further input, but the way I see it is this....since the CTO is linked to the 10Q filed on 08/15/2016, and it is related to the Master Supply Agrrement with Cosma S.p.A. - most likely concealing the costs associated with Metoclopramideh Hydrochloride Monohydrate USP - it would be listed in the 10Q as a R&D cost. When you look under R&D in the 10Q, there is this reference...
The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company currently depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its preclinical research and clinical trials. Other than an agreement with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, the Company does not have any other contractual relationships for the manufacture of commercial supplies of Gimoti. If Gimoti is approved by any regulatory agency, the Company intends to enter into agreements with third-party contract manufacturers for the commercial production at that time. The Company currently utilizes a third-party consultant, which it engages on an as-needed, hourly basis, to manage its manufacturing contractors.
I suspect because it's a contractual obligation, they may want to conceal how much they're actually paying for this product because they may be renegotiating the price in preparation of their NDA submission, and the eventual (or hopeful) approval by the FDA. This isn't looking good for the shorts! It's not a matter of IF this drug will be granted FDA approval, but WHEN. Hang onto your shorts! All IMVHO of course! GLTA!
