Over the last 6 months MSB’s obvious focus has been on the 2 AA opportunities for REVASCOR i.e. for end-stage CHF & for HLHS (both being covered by RMAT designations).
I feel confident that MSB has, over this period, been collating those materials/ draft materials that would be required for either of those 2 filings & could sensibly be prepared in advance. MSB personnel would have had ideas about the quality & extent of the evidence required for both those applications. There would have been feedback from FDA personnel on the quality of that evidence.
However, there’s no guarantee that the same subsets of materials, or even versions of currently available datasets updated to particular points in time would be necessarily appropriate for what’s being sought now. The timeframes to digest parts of these materials are no longer relevant.
It’s such an end-run. I’m still coming to grips with the idea.
So DREAM-HF data, the earlier LVAD trial data & the Boston Children’s Hospital trial data are the known knowns. They’ll all be used on this one, if it gets up. The FDA may even have by now feel that it has a degree of familiarity with each FDS. And if there’s been winking going on…well, I’m sitting here thinking ‘wow’.
This could all happen quickly - a filing this year is conceivable. Very exciting.
Cheers GTALTH
MSB Price at posting:
$1.85 Sentiment: Buy Disclosure: Held
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