Considering they have zero experience writing one and submitting one you better hope they partner and have the partner file the BLA, otherwise, it will be a long painful process....
You are aware that PPHM has a guy named Garnick working with them - if not, check his bio - he seems to have some pretty credible experience :)
What's the latest stat - thousands of pages submitted already.
First look-in coming soon. Next few weeks could be very interesting.
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