You All Should Listen to the Concall

So I spent the last 44 minutes listening to the conference call and I have come away feeling marginally optimistic and also relatively confident I have a decent reason for why the price falls yesterday.

Seriously though everybody really needs to listen to that conference call and draw their own conclusions as its pretty informative but here are mine.

1) I noticed another poster mentioned if injection into the heart is really viable for us as a treatment. I noted on the call that this was all achieved with a single injection of MPC's into the heart. Considering that this population is all rocking LVAD hardware then yeah I'm pretty sure they don't mind.....

2) The subset that showed very positive wean results was the older, ischemic in pretty bad shape patients. Which is the population that the CHF3 trial is targeting. There is a potential read through to that trial given patient populations are the same. But not enough people to know one way or another for sure at this point.

3) Oppenheimer asked to see evidence of improved heart function via echo-cardiograms, 6 minute walk tests etc. MSB basically handballed that a bit and said because they did not run the trial they don't have the data on this yet but it will be released (in the coming months). This point is a fairly important point in why the price fell yesterday. CHF is looking to see improved heart function. Our results yesterday INFER that but do not currently (with whats provided) demonstrate that.

4) NIH independently run trial is really the key part here. The NIH ran and organised this in a way they wanted. Following up on/progressing the trial in ways that suited them. This was great in that it didn't cost MSB money and the NIH seems to think its awesome results because they actually do give a stuff about GI Bleeding as its a major complication for LVAD and an unmet need. But it also contributed to yesterday being a shambles as MSB is still (like us) waiting on the data, the full data and having it properly combed over.

5) SI or another made the point that people being weanable in the trial was hard to demonstrate and in many ways not entirely helpful. As the population was largely comprised of younger more healthy people 2:1 that could naturally wean anyways. Older people where we had more success were only a small group but not enuogh to draw conclusions from.
Patients who don't wean well...........did show improvement.

6) Bell Potter lady said GI Bleeding hospitalization was way down over control. But noted that the incidence of hospitalization was still the same across the two groups. MSB tried to explain that and I'll admit I didn't fully grasp it but I felt she made a good point. Its hard to say who's right on that one.

What was abundantly clear in the  conference call though was they all cared very much about weaning and we were not able to draw clinical conclusions from the data presented. We have anecdotes that bode well for CHF but a larger bigger trial would need to be run to really know. So currently we can only assume (the results are good but not enough patient population to draw conclusions from).

Also the fact NIH ran the trial was helpful and hurtful at the same time. Its also very clear because the NIH ran and funded this thing that they do indeed care about GI Bleeding very much and the FDA we presume does as well. If we are approved by the FDA for this then we will become the standard of care for this area.

But thats why the price got smashed yesterday and will take time to recover.
1) NIH running the trial means we do not have all the answers or all the data ready to go from the moment the ANN was announced.
2) The market very much cared about weaning and we aren't able to answer that question yet. 
3) We did show good weaning results in the subset which is the focus of our CHF trial.
4) Because the data set is enough...........unfortunately it all left questions still unanswered.

But we do have a pathway for this being approved so thats great. But its overshadowed by the fact we don't have answers to weaning or demonstrated imrpoved heart function. Silviu's main point was that we are INFERRING improved heart function as GI Bleeding is a symptom of inflammation etc. But we don't have evidence to demonstrate improved heart function like what Oppenheimer asked for with 6 minute walk tests etc.

So yeah. Its good we have another potential candidate for approval but its very saddening that we don't really have any evidence to prove improved heart function at this stage beyond anecdotes. So because we don't know and we all hoped to get signposted this week by this trial, fear and I would say appropriate fear. Prevails.