Positive signal in CHF trial; LVAD trial-Takeaway.

CHF Trial (150-IM): I have come to conclusion that probability of success in this trial, especially in class iii heart failure, has increased significantly based on the following factors.

1. Trial design (Right target group): 80% out of 600 enrolled patients have ischemia heart failure. And 150-IM treatment showed significant improve in weaning in these patients group ( ischemia heart failure) in recently concluded phase 2b LVAD trials. It shows our treatment is more effective in this target patients. 
2. Pre-specified Interim Futility Analysis: Let's remind ourselves the fact that prespecified interim futility analysis of trials efficacy primary points in the first 270 patients (>45% of the sample size) were successfully achieved in April 2017. 
3. Last Month Review: Silvu stated that " as recently as last month 2018, the data monitoring committee reviewed safety and efficacy data in this trial and recommended continuation of the trial without modification having seen data from the first 526 randomized patients (87% of the sample size) and that includes the primary and secondary hospitalizations, terminal cardiac events and all safety data". Therefore,  i have formed the view that CHF trial's probability of success is higher. So, this program is very much positioned for partnerships.
4. Silvu Confidence: I'm viewing any bullish statement cautiously so placed this at no 4. "We believe this is a tremendous opportunity for the company and everything that we have learned to -date gives us great confidence in this target opportunity".  In Order to have great confidence Silvu itsecu and management must have the information that signalling it's success. And success means positive data and partnerships.

I've decided to double my investments in MSB again. These sell off, which might continue further , have presented us with an opportunity.

LVAD trial isn't failure because it has given us >500 Million market opportunity in GI bleeding and reduction is hospitalization. There isn't any treatment for this indication in LVAD patients which is number one cause of morbidity and hospitalization. MSB might get orphan designation for this indication.

How can LVAD trial could be that bad , it wiped off almost 40% of valuations?, because MSB failed to wean the patients from LVAD.  I'm satisfied by the silvu explanation of why primary endpoint wasn't achieved in this trial. On one hand, doctors working in this field were intrigued and excited by MSB effectiveness on GI bleeding and reduction in hospitalization rate on ischemia heart failure, on the other hand investors with limited knowledge on the field were panic selling because they saw the word" trial failed to achieve the primary endpoint". They completely ignore the  FDA advise to MSB  that -the very primary endpoints MSB had set and failed to achieve, is just biomarker and can't be approval in and itself. Instead, GI bleeding and hospitalizations are the clinically meaningful outcomes which MSB successfully achieved. 

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