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Chembio Diagnostics, Inc. Message Board

  • sonomaca sonomaca Dec 7, 2012 9:44 AM Flag


    Will not be at all surprised to see a delay. Either the FDA wasn't clear about what was required (and CEMI didn't ask) or CEMI just totally botched the most important submission in years.

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    • Too much speculation based on NOTHING........the FDA routinely asks for additional not expect ANY FDA application to sail through without dialogue between the FDA staff and the applicant in a "rolling" sort of way..........the fact that the FDA asked for more information and samples when it did....before the more evidence of a thorough review than suggest that our FDA plays favorites between competitors is totally without basis and should not be stated without hard evidence of such.........RELAX!!!!!

      • 1 Reply to mjh194353
      • I would agree with mjh on the bias thing. If the request would have come with more time left before expiration I would feel more comfortable. Not sure what the FDA calendar looks like, but the time of year is troubling as well with the holidays being here.
        In reading through the filing, it stated that if the information wasn't presented by today (Dec. 7th), then they would be looking at "up to" 180 delay. I'm backing off my earlier negative stance. I think we might just get there after all. I'm not concerned about the validation of the equipment, I'm wondering why more test kits were required so late in the game, and how much time that will take to get through that additional testing. That is the unknown. None of us can possibly surmise what it entails. If we take Larry at his word that it was ancillary, then all's good in the neighborhood.
        and your right db lots of skin in the game.

    • Question is, if there is a delay until next June (or, worse, outright rejection), as I now anticipate, is that already priced into the stock?

      I wonder if competitors have exerted some sort of influence over the process. Are we seeing the sort of bureaucratic "hurdles" sometimes found in other countries (if you catch my drift).

      • 1 Reply to sonomaca
      • dbretz Dec 7, 2012 12:21 PM Flag

        I won't say anymore about what's going to happen with FDA, as I guess I've said my peace in other posts on that.

        As to the question about exactly what's already baked into the cake as far as stock price, that's a good question. The biggest hurdle to figuring it out, obviously, is volume. It's still so low. And, recently, the lack of interest in this stock has really been shown by some of the huge spreads (at times) in the bid/ask. Just shows how few players there are. When you have a situation where there just aren't many investors in a stock, it's hard to know what the true market is/could be for it. Markets aren't made or moved until people actually get into them. Seibert is certainly doing his best to get the CEMI story out there. And volume is certainly up compared to the pre-RS days. But it's still far from where it needs to be to get a 100% feel of value. It's cheap right now on a price to sales basis. But you'd have to expect earnings to take a hit over the short term (meaning late 2013 through early 2015) if CEMI does decide to invest in jumping into the OTC market. A lot of the answer to your question depends on time horizon, I would suggest. But if you're asking short term, and you're assuming an FDA approval delay (an assumption I don't necessarily agree with, but let's go with it), I would think you'd have to expect somewhat of a hit. Of course, a lot would depend on the explanation for the delay. But Seibert has been out there essentially promising an FDA approval by year end. Even if it was just a technical delay, I would imagine that in the short term the stock would have to pay a price for the company not delivering on such an important promise and milestone. This is why I have said in so many other posts that if you have any doubts in CEMI's story and you bought in a couple of years ago or so, that the last several months would have been an absolutely, perfectly logical time to cash out. I would have expected volume to jump more than it did after the NASDAQ listing and with the investors road shows Seibert has been on. I'd be more nervous if I had the levels of skin in the game that some on the board I know have. Because there's not enough liquidity to exit in a timely fashion if you need to. But I feel that way about any stock, not just this one. I'd be thrilled to hear what others feel about all this.

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