Replies to post #7554 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>do you believe the 17th patient's data will be submitted as an "add-on" to the final BLA section, or, will they wait for the data first before submitting in its' entirety?<

I doubt that the 17th (last) patient will affect the critical path on the BLA timeline. While the last patient is being treated, GTC can be working on various facets of the data analysis and presentation. The only hang-up I can see is if treatment of the last patient were to extend into April—then the three-month post-treatment antibody data on this patient would not be available until July. Even in this case, however, GTC could presumably submit the antibody data on the last patient as a supplement with no change in the FDA action date on the BLA.