Ascendis Pharma A/S Corporate Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : So given that the deficiency or deficiencies were not outlined in the letter and I guess, recognizing the message you're sending on this call and with the press release that with the EAP open and extensions open, it would appear to not be a safety issue that the FDA said has. What can you say about how long do you think this might take to resolve? And then I have a follow-up.

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : Okay. And then just -- I'm sure people are wondering, has anything changed in the tone of the regulatory review or the topic of the FDA's questions they were focused on over the past couple of weeks?

Question: Andreas Argyrides - Wedbush Securities Inc., Research Division - Analyst : I'll try to ask in a different way here. So Jan, given the proximity to the PDUFA, it leads us to believe at least that this is -- there are probably some minor deficiencies that the FDA is not necessarily coming out and wanting to state, that they want to extend the PDUFA, though that may be the case. To what extent, given the timing and the fact that there's prior review, do you get the sense that these are readily addressable. Maybe you can just kind of comment there, I appreciate it.

Question: Andreas Argyrides - Wedbush Securities Inc., Research Division - Analyst : Okay, great. And a quick follow-up here. Do you think -- or do you have any knowledge as to whether what's going on with the FDA whether maybe they are experiencing delays in reviewing and this may be part of a delay on their end as opposed to anything specific again back with the filing?