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Tales from the Trenches™ with Sheila Mikhail, Co-founder and CEO of AskBio
The MATTER Health Podcast
The FDA's Reluctance to Develop a Drug in the Clinic
The FDA was being cautious because there had been a big red flag and they wanted to make sure, especially going into children that all of the precautions were taken. So in no way do I want to sound harsh to the FDA. It was just necessary growing pains considering this was almost like coming out of, you know, small academic centers. They weren't coming from big pharma with all of the sophistication. And so the field has matured a lot over the last 20 years.
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