hi Angelus512,1.) There are multiple treatments for established...

Allan. can you provide further commentary because I raise you 2 points.
1) I don't believe there is a treatment that exists at all to reduce G.I. bleeding so that's significant for MSB and the fda.

2) MSB showed statistically very large reductions so yeah regards you're I'm not sure it's at the level required to make it significant where did you get that from?

most especially considering zero treatment exists. so I'm confident the level required is a LOW bar.....

hi Angelus512,

1.) There are multiple treatments for established bleeding but I am also unaware of anything that prevents GI bleeding in LVAD patients (although I am no expert in this area). In that regard MSB has an opportunity if they can prove that the product works. However just because nothing else works doesn’t mean that the FDA will accept a lower level of evidence. This is a very expensive treatment, they will want data to show it works. A secondary outcome isn’t the same as a primary outcome.

2.) let me answer this with another question. Let’s say that a reduction in GI bleeding of the same magnitude was also was shown as a secondary effect in the chronic back pain trial, if you were the FDA would you approve injection of stem cells into the intervertebral disc as a treatment for GI bleeding? Or would you ask that other routes of delivery be studied?

I’m not saying that it won’t get approval at some point, but in my opinion based what I have seen the current trial is inadequate for approval.

Originally posted by angelus512