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Friday, April 29, 2016 3:57:00 PM
"Vitaros® is currently manufactured by Therapex, a division of E-Z-EM Canada Inc., a wholly-owned subsidiary of Bracco SpA in Italy (“Therapex”) and by Groupe Parima, Inc. Our third-party manufacturers are subject to numerous regulations, including Good Manufacturing Practices, (“cGMPs”), FDA regulations governing manufacturing processes and related activities and similar foreign regulations. Both of these manufacturers are located in Canada and are capable of providing commercial product for our partners." (emphasis added)
So what is the issue with manufacturing capacity?
I didn't say I was a happy camper. I'm not. But let's stick to the facts. I don't think the company can reach profitability in a year by increasing product sales hand over fist. However, the company's commitment that it will reduce operating expenses by 60% in 2017 is well within their control. The company stated that it will submit the NDA by end of 3Q16. That is not a high bar. After that it is in the FDA's hands and they have review timelines.
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