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Re: DanWebzster post# 219

Tuesday, 06/26/2018 6:25:12 PM

Tuesday, June 26, 2018 6:25:12 PM

Post# of 438
CLBS acquired global rights to a late-stage stem cell therapy from SHPG.

Their CMO guided this asset thru Ph1 & 2 studies at Baxter

CLBS will only owe milestones based on success

6/18 FDA granted the therapy RMAT status. This will allow CLBS to submit the therapy for approval w/o late stage trials

It's unclear how much additional work will be required to make this submission. a meeting with the FDA is in the works to clarify the next step.

The best possible outcome is a conditional approval followed by a confirmatory Ph3.

Cash runway will take CLBS into H1/20.

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