This is a game changer and the FDA has to study it closer than most of these. I believe the longer it takes, the decision will be more to a favorable side, than the negative. If they were leaning towards a further review, they would throw the ball back in NEPH court, not drag it out.
I don't trust the FDA. They are crooks and corruption still is present in this new administration. Don't say the longer it goes the better it is. Look at HEB. I know that this is a medical device and that was a drug. However the FDA never wanted Ampligen on the market. Big pharmas were involved in that decision for sure. The same thing could happen to NEPH. The big players don't want this device approved and who knows to what levels they will stoop to influence the crooks at the FDA. I am long also in NEPH, but I have no faith that the FDA will approve this at the moment. The FDA couldn't care less about the American public. It is a shame that the rest of the world is so far ahead of the Americans in the medical field and who's fault is that? Good luck to all of us. I hope the FDA comes to their senses and approves this thing finally.