Galectin Therapeutics Inc. (GALT)

[biotech2010]

These guidelines aren't 'favorable' at all for GALT since they focus on Clinical Outcomes, regardless of source, and not progression to Varices.

GALT's original plan was for the Ph3 to have a primary endpoint relating strictly to either reduction in HPVG or the progression to varices. The change to clinical outcomes adds other elements to the discussion that will affect the results since none of them will be helped by GR-MD-02.

Just look at slide 17 from July, 2018 regarding this: https://investor.galectintherapeutics.com/static-files/d114ffca-2367-48a2-99cc-ec0292d18fe1

This change by the FDA is the reason, IMO, why it has taken so long for GALT to finalize the Ph3 protocol.