SanFran,

I do not share the enthusiasm that you or others on this board have expressed regarding this news release. Have our standards sunk so low that our bellies are now full of these crumbs of information when we are well overdue a big piece of pumpkin ('tis the season) pie? I give today's news release a grade D.

Are we excited that our last webcast as around 320 days ago?

Are we excited that we still have no idea what changes if any have been/are going to be made to the BETonMACE protocol despite the news from 3 months ago that USA patients would be included?

Are we excited that we still have no idea if the futility analysis will occur at 50% of events or if it won't be announced until 75% events? Similarly, are we happy that because of this vague statement in the latest MD&A that we have no idea if we've reached the 50% mark (125 of original 250 events) yet?

Are we excited that they've gone from anticipating full enrollment by end of Fall 2017 to now anticipating full enrollment by H1 2018?

Let's break down those additional "nuggets" of information.

1.  Over 1950 patients are now enrolled in BonM - over 80% of planned enrollment.

Sure...that's great. They had ~1600 at the 4th DSMB report on 6/28/17. So they've added 350 patients in the past 4 months. However, a couple weeks later on 7/10/17, they anticipated full enrollment of the originally planned 2400 patients by Fall 2017. Enrollment slowed for some reason, no one can argue that. They will no longer be fully enrolled this Fall and now it won't be until H1 2018. Was it due to finances? Was it due to intentionally slowing enrollment to accomodate USA patients? A little of each? Today's news release keeps us guessing....and does not indicate if 2400 patients is still the target. 

2.  Some patients have now been dosed for over 100 weeks - 4 times longer than any previous trial

Yes, that statement is true. A classic Captian Obvious statement. We all know first patient was dosed 11/11/2015. What would have been more useful is clarifying whether they still intend to stop dosing after 104 weeks as originally stated. And before anyone replies saying "Well, the latest ClinicalTrials.gov update was changed to 120 weeks dosing!" No it wasn't. The trial has always had a 4-16 weeks safety follow up built in. All they did was remove "up to 104 weeks dosing" from the study title. Even the BIO Investor Forum slides from last month still indicated dosing up to 104 weeks. Nothing explicit has been stated about changes to dosing duration and we should still assume that it is 104 weeks dosing plus 4-16 week follow up (presumably off drug).

3.  Full enrollment expected in first half of 2018

See #1 above. They went from full enrollment Fall 2017 to full enrollment H1 2018. 

4.  Company now "looking forward to adding American patients in this Phase 3 trial"

I was more excited when they announced this over 3 months ago. The question now is what is taking so long? What protocol changes are you making (i.e. number of patients, number of target MACE events, study length, etc.)

I think there are some good clues above regarding the changes to the trial requested by the FDA....  Is planned enrollment now approximately 2,400 patients?

Really? Good clues? They gave us nothing! We already knew the original planned enrollment was 2400 patients.

I expected much more. We all should. They are still listed on the BIO Europe website as presenting on November 7th. Maybe....just maybe we'll get more answers then. Until then, I think today's nugget can just be flushed down the toilet.

BearDownAZ