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[43] We believe that the updated descriptor accurately reflects the devices intended to be described by C1739, inclusive of the SCOUT MD TM Delivery System, and addresses the applicant's concerns that the prior descriptor was overly broad

The economics of pharmaceutical development do create real evidence gaps for unpatentable molecules, and patients pay the cost of that asymmetry

However, the lack of extensive human clinical trials means long-term safety data in humans remains limited

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However, one potential side effect is polycythemia, a condition where the body produces too many red blood cells