Galectin Therapeutics Inc. (GALT)

[thefamilyman]

My take on it is NO delay... It sounds like they did submit an SPA to try to qualify this as a Phase 3 trial but got feedback that would have required a delay if they were to make the necessary adjustments and then "resubmit the SPA". They decided to proceed with this as a Phase 2 instead.

Getting that SPA to make this trial a Phase 3 could, in the long run, shorten the path to market. But the additional delay would not have been good for the share price. The delay might also have necessitated additional dilution which none of us want to see. Given that a successful Phase 2 could result in a share price that is a significant multiple (10X, 20X, or more?) of what it is today, I can agree with their decision "to proceed with the trial as a Phase 2 program."

From the PR...
"We submitted a special protocol assessment (SPA) with the FDA and received very useful feedback for the design of the study and the overall development program. At this time, and in order to move forward as quickly as possible and to take advantage of the myriad preparations in place, we have decided to proceed with the trial as a Phase 2 program, rather than resubmit the SPA to attempt to obtain designation as a Phase 3 trial currently."

Ahh. I see that, disappointing about the SPA.I suppose it's a delay in the larger sense but It doesn't appear to be a delay in the start of the trial, right? Says they are continuing on as a P2, just without SPA. Interesting teaser about the P1 fibrosis trial patient who had a remission of their psoriasis while taking GR-MD-02. Hope we'll hear something about the Yervoy trial soon.
- Darwinian