This Bell Potter Healthcare conference was the most bullish and enlightening update I have heard from MSB in a long time and deserves it own thread. We heard from SI, Paul (i assume Simmonds) and Jim O'Brien (although not much from Jim; but he is in Aus atm so I expect will be at the AGM) Here are my takeaways.
Expect CHF BLA to require another couple of months, not by the end of the year. Delays due to potency assays and manufacturing CMC work. This work underpins both CHF and CLBP.
Will have to do a confirmatory trial in CHF. The first approval (probably LVAD, will be an entry point. This allows you to get approval to price it, to launch it, and have physicians being comfortable with that product. Irrespective of whether CLBP or heart disease is approved first the ‘product will be available for multiple applications and indications’.
168 patients in the back pain trial were on opiods at baseline. Over 3 years of follow up 3 times the number that had Revascor came of opioids vs those that got the placebo. I guess we will have a discussion around what they think about that and pathways that we could help the FDA and the administration with their quest to reduce the opioid crisis.
CLPB trial will complete as planned but there is potentially another avenue or pathway, particularly patients that are taking opioids and are trying to reduce their opioids.
Adult GvHD trial delayed by 3 months with the US Govt shut down. First patient early in the new year. MSB have been making the product available to adult patients under compassionate use and the results have been terrific. We have seen patients with liver disease going to complete remission when they failed everything else. The physicians are using it and we have now had examples of insurance companies reimbursing it. Medicaid California is apparently the toughest to get reimbursed off label use and they were the ones to approve an adult to be treated.
Putting together a trial in UC which is a big unmet need.
I am really looking forward to the AGM is this is the level of information we are going to get.
