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Post by dreamboatcruise on Jul 14, 2015 10:52:25 GMT -5
My number is over $37.00. I see that happening when SANOFI gets EMA approval after the clamp study is completed in early 2016. Approval is unified but payer coverage is still national. Perhaps this warrants its' own thread but what sort of timeline do you see playing out getting payers to cover Afrezza in various countries? I guess I don't see EMA approval as being something that would project MNKD that much higher as there would still be room for shorts to claim that it is unlikely to paid for by providers in Europe... with them likely dredging up the ghost of "E" to exemplify this point. Is it possible that SNY is already working the access issue in EU in parallel with required trials? What's the best case time for getting Afrezza on formulary in UK, France, etc. ? |
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Post by kc on Jul 14, 2015 11:00:29 GMT -5
Lizzard I see them filing when they get the study results completed. I bet they already know the results of the studies being completed and just have to have it done officially. I read somewhere that EMA approval is a fast moving vehicle once they file it. So we can see perhaps approval in EMA countries within 12 months. Pricing in EMA countries? I bet cheaper than USA.
My number is over $37.00. I see that happening when SANOFI gets EMA approval after the clamp study is completed in early 2016. Approval is unified but payer coverage is still national. Perhaps this warrants its' own thread but what sort of timeline do you see playing out getting payers to cover Afrezza in various countries? I guess I don't see EMA approval as being something that would project MNKD that much higher as there would still be room for shorts to claim that it is unlikely to paid for by providers in Europe... with them likely dredging up the ghost of "E" to exemplify this point. Is it possible that SNY is already working the access issue in EU in parallel with required trials? What's the best case time for getting Afrezza on formulary in UK, France, etc. ? |
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Post by mnholdem on Jul 14, 2015 13:26:12 GMT -5
EMA approval process is 210 days maximum, followed by 30-45 days for final review. Trials data must be done BEFORE applying for centralized authorization to market Afrezza in Europe. Therefore, if all the EU trials are complete and data ready to submit for review, EMA approval could be granted by April/May 2016 if Sanofi applied this month.
EMA does have a fast-track process for a proven API, but I don't think Afrezza would qualify due to having a new delivery (inhalation) method, even if it is an old, proven, reliable API (insulin).
I don't know about Japan at all...
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I haven't quite worked out when to sell, but I don't believe it will be for a while (2-3 years). Also, to be completely honest, I do find myself thinking that after a major rally occurs, the shorts will simply set up camp higher up the mountain and continue using the tools at their disposal to drive down MNKD pps. Hopefully, during the next few years, short interests will be forced to set up Base Camp Two, Three, Four or even more...
I cannot help thinking that they won't go away until MNKD truly becomes an earnings-driven stock. I'm forced to consider that if MNKD rallies to $16 would it be just to watch shorts drive it back to $9? So I suppose "never-say-never" may apply here.
Regardless, I'm not too concerned about it AND it's reassuring to remember that MannKind plans to reveal/release a new drug every 6 months, even if we do have to wait a couple years for the first one (chuckle).
I do know that now is NOT the time to sell. I'm still buying shares and options.
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Post by bradleysbest on Jul 14, 2015 13:28:27 GMT -5
The potential is there for a couple of major catalysts (EU approval, DTC etc..) to get this snow ball rolling!
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Post by babaoriley on Jul 14, 2015 13:41:29 GMT -5
Don't get too far ahead, Bradley, did you mean "EMA submission?" Approval would be a great catalyst, but who wants to wait till that!  By the way, has anyone heard the rumor that the headquarters for the EMA is moving from London to Athens? |
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Post by bradleysbest on Jul 14, 2015 13:42:57 GMT -5
Yes (my bad) EMA submission. Spiro is on that rumor.....
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Post by papihoyos on Jul 19, 2015 15:54:40 GMT -5
if there is a quick run up, I would sell deep ITM calls against my position, otherwise I'll wait for Al which I imagine will be in the $25 range.
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Post by kball on Jul 19, 2015 20:05:14 GMT -5
if there is a quick run up, I would sell deep ITM calls against my position, otherwise I'll wait for Al which I imagine will be in the $25 range. Just hoping Al doesn't expire before those 2017 options do |
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Post by BlueCat on Jul 19, 2015 20:16:30 GMT -5
With Papihoyos.
And at that price, I may be waiting a while. Depending on what was happening at that time, I may just sell some to set some accounts back to where they were, and maintain a core for even better things down the road. But I think kball's point is quite right …. And not clear how the market will respond when the day does eventually come.
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By the way, has anyone heard the rumor that the headquarters for the EMA is moving from London to Athens?
