Galectin Therapeutics Inc. (GALT)

[biotech2010]

The most important thing (IMO) ever posted by GALT is in yesterday's 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."

The FDA classifies Phase 1 trials as proof of safety, Phase 2 as proof of Efficacy, and Phase 3 as proof of a product ready for market.

By GALT stating that they were considering bypassing Phase 2 and going directly to Phase 3 means they are convinced (after program review with the FDA) that the drug has already proven efficacy.

The market has chosen to completely overlook this statement, which is not surprising as it is buried in the PR.

I can't speak for anyone else but to say I am pleased with the progress is an understatement.