They should of have swapped the primary endpoints between the HF trial and CLBP. If they have chosen composite for HF, and non-composite for CLBP they would have struck gold twice. However, the outcome in terms of FDA approval pathway might be the same. The important thing today is that: THE CELLS WORK and MSB has discovered when their treatment will be most effective:
1) sr-GVHD in children (marker identified)
2) HF (class II patients)
3) CLBP (within 5 years of CLBP onset)
4) ARDS (high CRP, treat early)
Yes, we will need another phase 3 trial. but most drugs are approved with TWO phase-3 trials anyway and with an often very LARGE number of patients recruited in each trial. MSB has proven itself that the cells worked in all these indications and although at least ONE more trial is needed for all indications for FULL approval. With our market Cap of ~1B USD, it will be very interesting to see who MSB can bring onto the table to further these indications. The question for an investor is: what is the price of MSB in 5 years when we expect all these indications to complete their second Phase 3 trials and hopefully some have gained approval.
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