Thursday, December 28, 2017 12:34:50 PM
1. Uti trial is done already. They are just analyzing the data. This trial was able to enroll participant's significantly faster than anticipated and moved right along quickly. They have always said uti would be filed as supplementary indication to the original fda nda but what if the timeframe for the uti trail moved fast enough and they can just file it all together?
2. Dr. Horn resigned but his resignation isn't valid until this Friday dec 29th. During investors conference CEO was questioned about this and saif Dr. Horn didn't want to leave until he had all of his work done towards the filing of the NDA.
Adding all of this together in addition to the continued timeline of early 1st quarter as fda filing date, I think we can expect to see FDA filing for the NDA very, very soon in the new year. With the potential to have a double wammy of uti trial done and fda nda for both complicated uti and IAI all at once. Maybe it doesn't happen exactly like this but early 2018 should be good time to be a shareholder here.
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