GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Don’t you think [an FDA advisory panel] reduces risk rather than increasing it?<

If the ATryn data supporting the BLA had been weak, then perhaps a panel meeting would have increased the probability of approval for the simple reason that the downside from an unfavorable panel would have been very small.

However, we already know that the Atryn data supporting the BLA are strong. Hence, the downside from something untoward occurring at a panel meeting outweighs the potential upside from a favorable panel outcome, IMO. All told, I would rather have one fewer event in the parlay of events required for FDA approval.

>If the risk of approval is in the newness of the platform, I can easily see a risk-averse FDA delaying approval. OTOH, an advisory panel given the proper data including the EU approval and follow-up would more likely approve with an appropriate risk management plan.<

I’m not sure what you mean by a risk management plan for ATryn—please clarify. The term risk management plan is normally used to describe a means of restricting distribution for a high-risk drug such as Accutane, Thalomid, or Tysabri.