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Re: chmcnfunds post# 2350

Monday, 04/09/2018 11:23:17 AM

Monday, April 09, 2018 11:23:17 AM

Post# of 8305
Good presentation. Points to note

1. They filed for new IND in Mar as promised. We will know in 30-35 days if they can start the new trial - it will be a good catalyst

2. Key milestone still is Interim data and if it shows significant efficacy to stop the trial early - my view is - it is unlikely as FDA has agreed to give approval only based on one P3 trial results - so they will need to conduct full study- but good interim results will be another catalyst

3. The final topline results in Q4-2018
In my view, they will miss this milestone and it will be pushed to Q1-2019 at least
They have enrolled only 50% of 550 patients - the 1st milestone was delayed - it tells us that the enrollment is not as fast - they possibly cannot get another 280 patients in 6 months

Not very bad thing and I am ready for the delay. Final results should be good and we have a BO on hand IMO
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