Thursday, September 10, 2020 10:14:26 AM
The reality is very little is on the table w MM regardless of country. The FDA isn’t going to issue an EUA for MM and neither is the UK or EU. Do you really think doctors are going to prescribe an expensive injection to patients that are most likely going to recover on their own? If so at what point? Not until they fall into the SC symptoms which is no longer MM.
The SC trial is a complete different story. LL is the best option to save lives. That’s where the focus is coming from regardless of US, UK, or EU, however the approval runs through the FDA not around it. All agencies talk w each other.
The decision by the DSMC at SC interim is THE catalyst to pay close attention to. Odds are the trial is green lighted as it was at 149 patients — continue enrolling. It may be given EUA but it will still continues to completion as EUA is not an approval and full trial results will be need to gain approval.
The future is bright. Immediate reality is Nader pumped a meeting that was never going to deliver a quick EUA from the UK or EU for MM. Now he’s got to spin the meeting - which he will and will be left up to the market to interpret.
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