We just need to keep in mind that we now have full CMS approval for the pivotal trial and this was a major part of the delay with the EFS. This element of delay won’t be repeated. Plus the hospitals that we have already operated in will be a much smoother process.
Recruitment should also be quicker as there will be FDA backed US patient evidence to use in the recruitment process which there was not for the EFS. With potentially over 40 patients implanted by year end this will be seen less and less by patients as experimental.
So yes, recruitment will take time and onboarding hospitals will take time but we can’t or shouldn’t IMO use the delays with the EFS as a marker.
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