BIEL’s technology got the reclass to Class 2 by the FDA. This is gratifying for e a couple of reasons:

  • Class 3 would have wiped this stock out. Class 3 requires a prescription, but Class 2 will probably be OTC (over the counter) sales, at least for pain relief.
  • wound care (open wound) will still be Class 3
  • These are gratifying because I called it correctly in my previous blogs on this topic, so this gives me some confidence I know what I’m talking about. The advantage  (and disadvantage) of blogging opinions is there is a public record of being right or wrong. In this case I was right.
  • Right now, this stock is looking good. It spiked on the news but came back down, but we are dealing with some “dead air” here until the next smack of volatility strikes. Penny traders are insane, and push these stocks up and down. The challenge is to find a decent penny stock and try to ride the waves to some extent.
  • I was talking to the FDA prior and they did not steer me wrong, so I have to give them credit.
  • The next step for BIEL is to get some actual products approved for sale in the USA within the new reclass. Like a court date, this shouldn’t be taken for granted, but I am cautiously optimistic, I should say, bu I won;t say this. I am completely convinced BIEL gets the reclass approval and this has several immediate positives:
    • This will help get approval globally. Certain nations such as Taiwan are still holding out.
    • If BIEL gets one approval, they have about six other products ready to go, and they will all get approved too, eventually.
    • BIEL has sufficient clinical data to justify approval. A big German pharma (BRAUN) has helped with this, and there is a good osteoarthritis study out as well. The fundamental dynamic with this company was always there, but the reclass is enormously positive, and it is best to ignore the daytrading volatility swings. I expect volatility now, but would also look for accumulation going on by long termers.
  • All things considered the stock market is unsafe. Our basic economic structure is unsound. However,  the market probably will be propped up at least until there is a peaceful transition of power. Examples are 2000 and 2008 crashes, which occurred right after the elections. A war time president has never lost re-election in this country, so whoever gets in will be a two termer since war is the only trick the one trick ponies know for covering their asses.