U only need to read this:
"While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval."
AND THIS:
"We will work with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency's final decision will acknowledge the clear unmet medical need in this patient population," said Frank Condella, President and CEO of Columbia Laboratories, Inc.
"As was highlighted today, there are currently no products approved to reduce the risk of preterm birth in women with premature cervical shortening – an established strong predictor of preterm birth risk," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "The availability of a safe and effective product, with a demonstrated ability to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy, would represent a significant advance in the prevention of early preterm birth and its associated complications."
****FREE $$$$. NO JOKE. KIND IMAGIN WHAT TIME CONSIDERATION INVESTORS USE THESE DAYS. DOES ANYONE REALLY THINK THIS WOULD NOT BE APPROVED. CHANCES OF APPROVAL vs NONAPPROVAL IMHO IS 70/30
