Albireo (ALBO)

[rocketeer357]

ALXA was torpedoed by the FDA for safety issues in Phase I, even though these issues were non-existent in later trials.

To me the FDA's message is clear: any question raised at any point in any trial makes the drug unprovable.

How can the FDA overlook the faulty India results? Even if the company has provided sufficient data, IMO it's a huge gamble to think that the FDA would want to set a precedent by approving a drug that has ANY issues at any stage of testing.

Best case scenario: conduct the trial again and re-submit when complete.