Cell Therapy News/Articles, page-772

@bennelong

What absolute revisionist BS.

The primary endpoint for the LVAD trial was of particular interest to MSB and widely referred to right up until they discovered it failed. Show me the announcement prior to November 11, 2018 that MSB had a meeting with the FDA where weaning was discussed that it wasn't meaningful? There is no announcement. MSB only announced this FDA meeting about GI bleeding after the PRIMARY ENDPOINT FAILED ALONG WITH 8 OTHER ENDPOINTS. It just suited their narrative, and if they did have a meeting prior to the trial results, well then that should fall under continuous disclosure....and you are a revisionist.....

I see you've partially quoted what the moderator of the AHA session said - would you care to post full transcript? Go on....

For those readers who have a healthy sense of doubt.....I have 3 things to inform you.

1) FDA have given guidance on a pathway to regulatory approval. I sum it up as best as this "There's no way we are going to accept a BLA on this. You have to run another phase 3, and endpoints are going to have to change, and we are going to have to see a lot more improvement that can benefit the patient and the health system than the read-out results from this trial".

because:

2) Reduction in GI Bleeding isn't a result for repair of the heart - in fact nothing in the trial suggested improvement in the cardiac function (good luck for the CHF trial). And the reduction in bleeding didn't result in reduction of post-operative hospital admissions.

and

3) A confirmatory trial isn't what most people think it is. It's purpose is not to confirm the results of a previous trial. A confirmatory trial is a type of trial that states a hypothesis in advance and evaluated to a protocol. DON'T GET SUCKED INTO THE WORD CONFIRMATORY. They aren't running it to prove how good the results of the last trial were, because they weren't.

Enjoy your weekend.