Clearly, something's afoot. They hired an IB, and now we're getting actions preliminary to a transaction, ie clearing out old warrant holder claims. As to the nature of the transaction, if this were merely CBMX buying another company, there would be no need to deal with the warrant holders as such. Nothing in the capital structure would have changed. So, my guess is that either CBMX is being bought or there will be some sort of all-stock deal, which makes more sense given CBMX's cash position.
I'm surprised they haven't gotten ANVISA approval. The test was developed with Fiocruz, tested in Brazil, and submitted quite some time ago. Sperzel's claim that CEMI would see significant Zika revenue in 2016 is looking a bit shaky at the moment.
CEMI failed to get FDA EUA for Ebola, the reasons being that OSUR's test was superior and was submitted earlier. CEMI got the Zika application in early this time. As to WHO, CEMI is at the back of a very long line. Clearly, they were prioritizing ANVISA and FDA.
CEMI never got EUA for Ebola, probably because they were too late and/or the product was inferior to OSUR's. I think, at this point, they've really got to deliver on Zika.
CEMI has not gotten follow-up cash for development of Zika. Perhaps funders are waiting for approvals before they commit.
He's a US sales and marketing specialist. When he first came on board, he had nothing to sell. Now, he's got three products. Next year, he'll have four (most likely). I predict, BTW, CEMI is going to buy another product or two for sale in the US.
If he makes a decision to slash prices to $5, I am very confident it's the right call. CEMI has been targeting the public health market. They know who the buyers are, and they understand the sales cycle, ie when purchasing decisions are made.
Regarding Zika, the Bahia Farma product was approved. It seems to have been developed by a Korean company, and is manufactured by BioCAN. CEMI really needs to get Anvisa approval rapidamente!
Now, Alere has to sell their stock at cost. Also, this likely puts pressure on Alere to cut cost of Determine Combo, at least some. Public health agencies don't have much money these days. The $12 or whatever Alere charges for Determine Combo is going to seem like a big premium.
Now, TRIB has to suffer through a round of price cuts. What's more, CEMI's HIV-Syph test is going to completely destroy whatever market TRIB has built for its Syph test. TRIB's dumb management could have bought CEMI, but they got cheap.
So, you know exactly why the stock is down? You're all knowing. You must be the world's richest man. Never mind that another company beat CEMI to the punch in Brazil. Not relevant, in your book. Why? Oh, because you're all knowing. Idiot.
A company called Bahiapharm has just gotten ANVISA approval for its Zika test. It's the first POC Zika. Also, the epidemic in Brazil seems to be waning a bit. Seems to be seasonal, as one would expect. Also, seems that acquired immunity might play a role.
ANVISA and FDA EUA are filed. I think the pullback we saw this week may be related to lack of timely approvals. I would seriously doubt that CEMI would submit a test for approval which wasn't rock solid, but who knows. The FDA has approved for EUA for several PCR tests, but those are near 100% sensitivity/specificity. POC might not be able to achieve those levels.
False negative is really the issue. If a patient tests positive, they would certainly be referred to PCR for confirmation. However, the implications for false negative are dire, indeed. DPP ZIka has got to be near 100% sensitive, and that's a fact.