Biotech Values

[rkrw]

<<<If you think delivering Squalamine as a systemic IS NOT a safety concern with the current mindset at the FDA then you have not done your homework.>>>

Why do you guys keep saying "current mindset" of the fda? You think testing the safety of drugs is something new?

Just like any other drug, genr will have to do LT safety studies. Maybe the bar is a little higher and they'll have to test in a few more patients, maybe for a little longer. If it's proven clean and the drug works well, they should be in good shape. If its not clean or SAE's emerge, then poof, kiss it goodbye. The current mindset hasn't shifted, this is the way it always was.