Biotech Values

[croumagnon]

Blood safety is not an issue with Polyheme

You started by saying it is an issue because it relies on blood and then went on to clarify that you realize the processing theoretically can clean up the blood! So, in essence you contradicted yourself except to state that this was not what is currently being validated with the FDA.

"NFLD will do real well until their current inventory is gone then they'll be stuck"

I think not because Polyheme can just as easily be made (and is often made) by the discarded blood supply which must be discarded after 40 days I believe, so supply is not an issue. Additionally, since as you yourself recognized, the process cleans up the blood so that a contaminated blood supply would not be an issue.

"Last I heard, that wasn't the manufacturing process they were validating with the FDA. So you can toss that theory out the window until they run prospective safety trials using bad blood on the input side.'

Also not really correct because the trial itself will be comparing the use of Polyheme Vs Saline+Blood so any adverse events present in the blood and not in Polyheme could actually provide a safety demonstration. This is not the approval they are trying to demonstrate here but some anectodal evidence may emerge from the trial nevertheless.