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Post by liane on Oct 22, 2013 15:48:01 GMT -5
I know it's been pretty quiet around here - hopefully that will all change for the better in the next few days as real news from MNKD starts to pour in. Just wanted to thank everyone who takes the time to post here or even just stops by to check what's new. Looking at the YMB today - it's more of a cesspool than usual - so we must be getting close. Hang in there everyone!
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Post by slushy on Oct 22, 2013 16:40:22 GMT -5
Thanks for the check in liane! I'm here multiple times a day, everyday. Like you said, YMB is a cesspool so even when it's quiet on this board I'd rather read one post here than 20 troll posts over there. Are you expecting any specific news the next few days? Or just being hopeful?
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Post by liane on Oct 22, 2013 17:18:42 GMT -5
Well, as you know, MNKD filed the NDA resubmission on Sun 10/13 - which means the FDA has 14 calendar days to accept it and assign a PDUFA date. Not sure if we would hear on Friday or on Monday. Now nothing has been publicly stated that this would be anything but a Class II submission (ie 6 months to PDUFA), but I've always held a small hope that it would be fast-tracked and have a 2 month review. Certainly, I would not place a bet on that, but I do have an increasingly strong gut feeling it may go that way. But what would that mean??? We could have an approved drug on 12/13!!! That would mean very little time to have a partner on board and be up and running - unless all this has been worked on in the background already... Thus the need for all the creative financing lately.
Other events - warrants expire next week - so hopefully these short hedging strategies will get unwound. I would think too that if Deerfield will convert, it will do it now. I had previously thought they would do it after that flatline in the share price in Sept - thinking they would not be able to make a sustained effort at driving the price lower - but I guess I miscalculated the effect of the warrant execution. Also, soon I expect we hear about the EU submission. And, Al had mentioned that some unnamed country might approve Afrezza even before the FDA. So a lot is about to happen in the next couple of weeks.
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Post by babaoriley on Oct 22, 2013 20:10:30 GMT -5
Liane, it seems you're quite optimistic about some good news soon. I don't share your optimism, but hope you are right. For example, I just hope we get our PDUFA date set in the next week and anytime in April 2014 is fine with me, rather than hear that the FDA wants "just one more thing" to complete the submission. Fast track, you are reaching, Liane; and I will eat crow here (and lobster that night) if your hunch is correct!
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Post by rtccpa on Oct 22, 2013 20:17:45 GMT -5
Can't take the wait much longer.
Root canal would be less aggravating than this.
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Post by nemzter on Oct 23, 2013 10:34:15 GMT -5
I sure hope you're right Liane! I log in every day to watch and look out for announcements.
I just don't want to miss out on the short squeeze and would be happily sitting at home watching the shorts covering in panic mode...
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Post by liane on Oct 23, 2013 11:06:39 GMT -5
Baba,
I am optimistic, and it is just a hunch. But i am also well grounded and not counting on Fast track.
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Post by babaoriley on Oct 23, 2013 11:17:47 GMT -5
I'll be happy with any kind of track that gets us approved in the first half of 2014! Gosh, it would be nice to have a money-grubbing, but large partner on board well before then, though!
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Post by rak5555 on Oct 28, 2013 9:04:20 GMT -5
Hello all! Just back from 10 days in the Rockies chasing elk. I have perused the board and it looks like I missed nothing. Now I am wondering what will come first: Q3 earnings CC or PR announcing filing has been accepted.
BTW - does anyone know how many pages this filing contains?
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Post by BD on Oct 28, 2013 9:10:02 GMT -5
BTW - does anyone know how many pages this filing contains? I know no-THINK. No-THINK! |
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