Robbie here is the note from Morgans
Paradigm Bio.
Off the fence and back to a Reduce
PAR has announced it has finally received clearance from the US FDA for its
major trial for knee osteoarthritis. The announcement comes after a large
number of additional non-clinical studies and resubmissions to the FDA were
required in order to satisfy a number of concerns held around toxicology,
pharmacokinetics, and minimally effective dosage rates. The news comes as a
relief for shareholders which has seen the share price deteriorate significantly
over the last 12-18 months. However, looking forward we expect an update on
trial cost and timeline revisions to temper the relief rally and highlight increased
capital requirements. We make no changes to our long-term assumptions and
see risk to consensus expectations versus our view of narrower marketability,
higher competition, higher capital requirements, and IP concerns.
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