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Post by cgiscgis on May 10, 2016 16:34:37 GMT -5
If Matt had imminent international deals very close to be finalized, why not wait with the dilution? Or was the dilution a strategic move to appease institutions before the sharp rise in share price? I am recently struggling a lot to understand Matt. I am long and willing to ride it out, but the shareholders meeting promises to be quite entertaining.
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Post by Deleted on May 10, 2016 16:44:07 GMT -5
IMO Dilution was necessary to tell these international partner possibilities to increase their offer because they are probably getting low balled.
House is being foreclosed on in 24 hours do you offer current market value? Of course not. The seller is in a bind so you try to low ball them.
They are cash poor and they are getting low ball offers. Whether these guys come back with better offers or wait it out is another story. Or maybe there are none and Matt is full of shit. Could very well be true. Its impossible to figure this out.
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Post by laffs4sale on May 10, 2016 16:47:41 GMT -5
With the cash infusion, we may not need an international deal now. It cuts both ways.
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Post by Deleted on May 10, 2016 16:55:34 GMT -5
With the cash infusion, we may not need an international deal now. It cuts both ways. IMO they 100% need both and as a share holder I want as many as possible. There are plenty of diabetics in the US for us to have a successful company. |
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Post by mnkdfann on May 10, 2016 17:06:41 GMT -5
IMO Dilution was necessary to tell these international partner possibilities to increase their offer because they are probably getting low balled. House is being foreclosed on in 24 hours do you offer current market value? Of course not. The seller is in a bind so you try to low ball them. In that case, the move would have been far more impressive had Mannkind not issued its shares at such a yuuge discount in this offering. |
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Post by curiousdoc on May 10, 2016 20:20:26 GMT -5
With the cash infusion, we may not need an international deal now. It cuts both ways. IMO they 100% need both and as a share holder I want as many as possible. There are plenty of diabetics in the US for us to have a successful company. Agreed. I don't think the cash runway is even half as long as it needs to be at this point. |
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Post by agedhippie on May 10, 2016 21:38:30 GMT -5
IMO they 100% need both and as a share holder I want as many as possible. There are plenty of diabetics in the US for us to have a successful company. Agreed. I don't think the cash runway is even half as long as it needs to be at this point. I don't think it is either. I can see at least one more cash raise and most likely two. Hopefully some of that can be debt rather than dilution. |
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Post by kc on May 10, 2016 22:00:02 GMT -5
With the cash infusion, we may not need an international deal now. It cuts both ways. IMO they 100% need both and as a share holder I want as many as possible. There are plenty of diabetics in the US for us to have a successful company. We need an international deal to bring in some sales and to get better exposure worldwide to work to be a block buster product . |
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Post by peppy on May 11, 2016 7:45:39 GMT -5
My understanding is an international deal requires approval to sell afrezza in that country. In Europe for instance my understanding is the cost of the application to ask for approval in Europe from the European Medical Agency is @ $250,000. (Among, The reasons Sanofi never applied? Along with Sanofi would never get the price it was charging for afrezza in the USA in Europe and they knew it. Sanofi playing America for the fools we are? 5% world population using 75% of the world prescription drugs? )
Is that application cost information more or less correct?
Are all international partnerships the same, "if you want to play, you have to pay?"
Just asking
www.ema.europa.eu/ema/
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Post by kball on May 11, 2016 8:26:01 GMT -5
IMO they 100% need both and as a share holder I want as many as possible. There are plenty of diabetics in the US for us to have a successful company.
We need an international deal to bring in some sales and to get better exposure worldwide to work to be a block buster product . Just our luck, Matt had a sweet deal ready to go with El Chapo, but then... |
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Post by greg on May 11, 2016 8:50:09 GMT -5
My understanding is an international deal requires approval to sell afrezza in that country. In Europe for instance my understanding is the cost of the application to ask for approval in Europe from the European Medical Agency is @ $250,000. (Among, The reasons Sanofi never applied? Along with Sanofi would never get the price it was charging for afrezza in the USA in Europe and they knew it. Sanofi playing America for the fools we are? 5% world population using 75% of the world prescription drugs? )
Is that application cost information more or less correct?
Are all international partnerships the same, "if you want to play, you have to pay?"
Just asking
www.ema.europa.eu/ema/
The application cost for the EMA is in the ballpark. It was never a reason for Sanofi not filing an application there. Sny generates annual revenues in the neighborhood of $35 billion and profits of around $5 billion. What's a quarter million? Not even a drop in the proverbial bucket. It's impossible to know definitively why they never filed in Europe but I was told last August that the company never intended to sell Afrezza in that market. Why not? Who knows!! As to your initial statement..... all international deals are completely up to the parties involved. One deal, for example, might be contingent on the drug's developer to first get approval, whereas another deal might require the int'l partner to apply and get the approval. For MannKind's purposes, though, given it is based in the U.S. and does need money, a deal would undoubtedly require that the partner has expertise/experience in its particular region and the resources not only to get approval but also to market effectively. |
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Post by peppy on May 11, 2016 8:59:13 GMT -5
My understanding is an international deal requires approval to sell afrezza in that country. In Europe for instance my understanding is the cost of the application to ask for approval in Europe from the European Medical Agency is @ $250,000. (Among, The reasons Sanofi never applied? Along with Sanofi would never get the price it was charging for afrezza in the USA in Europe and they knew it. Sanofi playing America for the fools we are? 5% world population using 75% of the world prescription drugs? )
Is that application cost information more or less correct?
Are all international partnerships the same, "if you want to play, you have to pay?"
Just asking
www.ema.europa.eu/ema/
The application cost for the EMA is in the ballpark. It was never a reason for Sanofi not filing an application there. Sny generates annual revenues in the neighborhood of $35 billion and profits of around $5 billion. What's a quarter million? Not even a drop in the proverbial bucket. It's impossible to know definitively why they never filed in Europe but I was told last August that the company never intended to sell Afrezza in that market. Why not? Who knows!! As to your initial statement..... all international deals are completely up to the parties involved. One deal, for example, might be contingent on the drug's developer to first get approval, whereas another deal might require the int'l partner to apply and get the approval. For MannKind's purposes, though, given it is based in the U.S. and does need money, a deal would undoubtedly require that the partner has expertise/experience in its particular region and the resources not only to get approval but also to market effectively. Quote: deal might require the int'l partner to apply and get the approval. reply: I imagine that this is the deal MNKD is looking for.
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Post by greg on May 11, 2016 9:15:32 GMT -5
Peppy,
Absolutely. Even in countries where additional trials aren't required, an application has to be filed. Keep in mind that even the applications will be in foreign languages, Arabic, Chinese, and Japanese, to name a few. MNKD doesn't even have the expertise or knowhow to complete the application, let alone navigate the agencies that would review the application. Sanofi was tasked with conducted the additional trials, where necessary, and filing the applications. Any new partner(s) would undoubtedly have to do the same.
MNKD investors have to realize that negotiating such a deal takes time, also keeping in mind that the prospective partners have to do their own due diligence. This would most likely also include conducting field research to determine demand and appropriate price, to make sure a deal is worth doing. We have to keep in mind, too, that they have their own time table, and that has nothing to do with our dire need for cash.
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Post by matt on May 11, 2016 9:51:06 GMT -5
My understanding is an international deal requires approval to sell afrezza in that country. In Europe for instance my understanding is the cost of the application to ask for approval in Europe from the European Medical Agency is @ $250,000. (Among, The reasons Sanofi never applied? Along with Sanofi would never get the price it was charging for afrezza in the USA in Europe and they knew it. Sanofi playing America for the fools we are? 5% world population using 75% of the world prescription drugs? )
Is that application cost information more or less correct?
Are all international partnerships the same, "if you want to play, you have to pay?"
Just asking
www.ema.europa.eu/ema/
I haven't done one in a while, but I think your stated price for an EMEA approval is correct. As I recall, if you are an SME (small or medium enterprise) they cut you something of a discount, but do you really want a partner that is an SME? I doubt it was the 250,000 Euro cost to apply that dissuaded Sanofi; it might have been some of the other EMEA requirements such as completion of a separate pediatric trial that perhaps MNKD could not fund and Sanofi did not want to fund. International partnerships are like people; they come in all colors, shapes and sizes. As a general rule, the markets with the lightest regulatory hurdles (i.e. show us a copy of your FDA approval and fill out this form) are also the ones with the smallest markets. New Zealand comes to mind. Those with high regulatory bars are those with larger populations and high prices. Japan for example. In all cases there are costs to be managed and the only question is which partner is going to write the check. It comes down to the choice of whether you want MNKD to write the check and get better pricing from the partner, or whether you want the partner to write the check and take it out of MNKD in a higher profit share. There is no free lunch.
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Post by factspls88 on May 11, 2016 9:58:05 GMT -5
If I had to guess, I would think that some entity in Israel would be a likely partner given the mnkd's recent registration in their stock market.
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