Expert Calls: Former FDA CDER & Current FDA IP Lawyer's Thoughts Compounding
Summarized notes from two lawyers on the GLP-1 shortage and compounding post-shortage
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Discussion Notes
Just like our previous expert call with an FDA lawyer, we had the privilege to have an informal chat with a prior FDA Lawyer who worked for the FDA and helped write the guidelines for compounding while there.
This conversation was very informal and we’ve summarized the quick call below.
However, BofA was able to have a call with an FDA patent attorney last year to really go in deep and understand the compounding industry, the risks associated with doing so, and what, if at all, a world for HIMS would look like once the shortage has been resolved.
We found this conversation very informative and reinforced our thesis once again that HIMS will not be able to compound at scale despite what they’ve been alluding to over the last 6 months.
A summary of that call is found below as well as the full transcript for you to read and analyze yourself.
If you haven’t already, in addition to publishing this report, we’ve also posted an updated report on HIMS regarding updated credit card sales data and the concerning takeaways we found over the weekend.
Enjoy.