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Endocyte, Inc's CEO Discusses Second Quarter Results - Earnings Call Transcript

We right now believe we have plenty of supply to cover us through the end of the year and that's when we anticipate that DOXIL should be coming back online, according to announcements from Janssen or J&J.

We also point out that we've been working closely with Janssen on this supply purchase and they've recognized the importance of the PROCEED trial and will work with us to help us make sure we get as much stock that's available.

Second thing is the EU filing update. We continue to have good interactions and frequent interactions with the EU regulators. We have the vintafolide filing, which is EC145, ready to go.

We had some discussion recently with the EU where they have asked us to put all the filings in at one time. We were going to do them sequential but they have requested that they come in all at one time, both the imaging and the therapeutic filing.

And so we'll probably have all of those go in in the fourth quarter. It's not going to delay the review period at all. It's just a request by the EU to see – so that they don't have them come in one time period and one in the other. So we're anticipating the filing will happen this year and we'll have all applications go in at one time.

Ig uses another comment on Merck, we've been very happy with the interactions of Merck so far. There has been a lot of work in preparation for the EU filing as well as potential commercialization in EU.

We've been transitioning the manufacturing responsibilities for – of ertarfolatide or the EC145 to Merck. We're working with them on the new indications that they will be running besides the ovarian and lung study.

And we're appreciating, I guess, the immediate commercial horsepower of Merck as we work through launch plans and start to enhance KOL relationships. And so really – and also they have been spectacular as a partner to work with.

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