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Expert Financial Analysis and Reporting

FDA Announces July 12 AdCom Meeting for CTL-019: Thoughts on How This Might Affect Investor Perceptions of Kite (KITE, Neutral, $80.25) and Cryoport (CYRX, Buy, $3.89)

The FDA has announced that there will be an AdCom meeting for Novartis’ CTL-019 for the treatment of pediatric r/r ALL on July 12. In my June 5th note, I wrote that Novartis was expecting an AdCom meeting for the pediatric r/r ALL indication. The PDUFA date is in late September but I think that approval could come slightly sooner, perhaps in early August.

I think that this means that the FDA will also schedule an AdCom for Kite’s Axi-Cel in the r/r DLBCL indication. Using the FDA’s timing on scheduling the pediatric r/r ALL AdCom after accepting the BLA, this could occur in September or early October.

The next question is whether the FDA will require an AdCom meeting for Novartis’ CLT-019 in r/r DLBCL. I see three possibilities:

  • The FDA holds an AdCom for Axi-Cel and CTL-019 on the same day and goes on to approve both products at the same time. I think that the FDA will want to compare the data from these two products side by side. This is my most likely scenario.
  • The FDA holds an AdCom for Axi-Cel but holds one later for CTL-019. In this event, Axi-Cel could come to market a few months before CTL-019 in this indication.
  • The FDA doesn’t require an AdCom meeting for CTL-019.In this event, CTL-019 could come to market at the same time as Axi-Cel or a few months later.

One of my reasons for caution on Kite’s stock at this price is that I believe the consensus expectation is that Axi-Cel will be approved a few months before CTL-019 in r/r DLBCL. It could be a moderate disappointment if investors conclude that Kite won’t have first mover advantage.

The fast FDA action in quickly scheduling an AdCom for CTL-019 signals that it wants the CAR-T products on the market. This is a strong positive for Cryoport which is my preferred way to invest in the CAR-T launches. I have not, as yet, included any revenues from CAR-T launches in 2017 projections.

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