"Al Mann was less ambiguous, in a phone conversation with PharmExec. “I would expect it to be approved in mid-April ,” says Mann. “On our schedule it looks like April 14, but it could be a few days before or after.” Mann says his company will file in Europe shortly after completing the US submission. Mann says other markets are looking to the FDA and EMA as a guide on this product; however, “a number of countries are talking about approving [Afrezza] simultaneously…and one country is even talking about doing it before the US.” Which country is that? Mann wouldn’t say."
I saw this being questioned in the recent MF article as well. I am wondering if this might be a bad transcription of the conversation, in that Mr Mann might have been refering to Apr 2014. I know it says a few days before or after but wondering if this could possibly be refering to sometime in Mar or May?
Just thinking out loud,
Sentiment: Strong Buy
China is not the answer. If you want to know how China treats a new drug that is effective for a serious health condition then check out what they did to Novartis' Gleevec. In order to sell in China, the government made Novartis agree to give 3 doses free for every one they sell to the government. Guess who runs the healthcare system in socialist China? Except for the wealthy, the majority of the population is on the government healthcare system and depend on its catalogue of accepted drugs. Money can be made but as much as you think would be realized by the pharmaceuticals.
That would mean he is confident of a priority 6-month review. Hopefully he is basing these statements on some solid communications with FDA. One thing which has been bugging me is that the math is so compelling as regards even minimal market capture, and yet we don't seem to have any heavy accumulation by really big players taking place, at least the shorts don't appear to have added greatly to their short position in an effort to keep the share price down under $6. I expected the recent short stats to indicate a hefty short count increase to maybe 51 or 52 million shares, but it seems to be holding steady at about 48 million. It just seems such a no-brainer that Afrezza will capture at least 10% of the prandial market (I expect much greater capture), and that figure alone should result in a meteoric share price past $25. So I can't figure why there isn't currently a huge rush into MNKD shares, it just doesn't compute for me.
Mann has never been especially measured with his statements to the press. I think that this is a good indication of what he's been up to and a best possible timeline, but I'm not counting, my chickens before they hatch. The next announcement might be a partnership and he didn't seem to give any color regarding that.
Great find and thank you. Just read the article and it was most interesting to see Al's statement the European filing will occur shortly after U.S. application is resubmitted in October. There was no mention about partnership talks, but it seems to me if they are going file outside the U.S. so soon, they must have a deal done. Today's SEC filing also seems to indicates something has happened. Tomorrow should be interesting. Thanks again for finding the article.
Outstanding. Imagine if the one country contemplating approval before FDA rules is India, or China - guys, MNKD could easily open at $12, and run to $18 as the shorts stampede to cover........that is before the FDA gives a thumbs up mind you.