Wednesday, February 08, 2017 11:40:05 AM
My bias: I am a long, had shares since 2013
* The call was not negative, nor was it overly positive in the sense that we feel good about even being in this trial in 2017.
* They are close, but the question is really HOW close, and what does that mean for us as shareholders? Great that FDA said next step is submitting the IND.
* Becoming a pivotal trial and enrolling 100 people - While that is great for the long term it is potentially NOT great for our short term outlook from a PPS standpoint. Making this a pivotal trial means the costs to run this trial are going to go way way way up. It also means most likely the trial length will be much longer. I simply don't see how you run a pivotal trial with a 6 month hard stop and 1 year trial. Most P3 trials are 3 years, and cost a ton more money.
* The partnerships, funding that he mentioned. Those are relationships that take time. I assume that while right now we dont need money, to make this a pivotal trial we DO need to get more funding. I would like to know more about what the costs of a pivotal trial would be.
* I would like to know what their timeframe is to decide if they are going to change the design to make this a pivotal trial
* Everything I said, only effects things in the here and now. If they make this a pivotal trial, all shareholders are greatly benefited from it happening, and so are future patients.
* If I was personally guessing, my hope is that this clinical starts in 2017. I would say based on how i took things, its 50/50 that will happen. I think seeing hard stop data in 2017 is a MAJOR grasp.
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