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Re: Chappy86 post# 976

Tuesday, 08/14/2018 11:58:01 AM

Tuesday, August 14, 2018 11:58:01 AM

Post# of 2496
I am personally not expecting much. It has been pretty apparent that all their resources have been focused on getting through the interim analysis. In their Q1 call they pretty much stated that their product is superior to what is available in the EU, but without strong clinical study data to support it, it doesn't sound like they ere expecting to gain much traction. Data and FDA approval would be the traction to expand in those markets.

"I have been asked several times about our business in Europe and the Middle East and why our Neutrolin sales are insignificant. Let me answer this question. The European, Middle East markets are different from the U.S. market. There are several alternatives for catheter lock solutions on the Europe, Middle East markets, the majority of which are citrate-based with a variety of concentrations and sold at very low prices.

The citrate concentrations that are used in this market in our opinion do not have the anti-microbial firepower to significantly prevent CRBSI. There seems to be little to no robust data that is randomized, double blind control trials that show the efficacy and safety of these citrate catheter solutions.

In order to penetrate this market, we will need to thrive competitively and have compelling clinical data for Neutrolin."
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