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Post by thekindaguyiyam on Apr 7, 2014 4:04:30 GMT -5
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Post by babaoriley on Apr 7, 2014 6:25:44 GMT -5
I'm thinking of a word that begins with "f"...
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Post by notamnkdmillionaire on Apr 7, 2014 6:36:52 GMT -5
I thinking of a word that begins with "f"... "finally?" "fun?" "fantastic?" "fortunate?" Am I close with any of my guesses?
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Deleted
Deleted Member
Posts: 0
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Post by Deleted on Apr 7, 2014 6:46:15 GMT -5
I am not happy at all, but I was expecting this from the time the advisory committee was announced.
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Post by ashiwi on Apr 7, 2014 7:01:53 GMT -5
Baba you took the word out of my mouth. As a matter of fact that was the 1st word out of my mouth this morning. Mondays are tough enough. Not the way I like to wake up on a Monday
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Post by babaoriley on Apr 7, 2014 7:16:07 GMT -5
I'm only up at these wee Pacific time hours because of some heartburn, so I figured I'd come sit at the computer for a while, and let the condition subside and become drowsy (generally works well for me). The word "ironic" is very over and mis-used, however, I think it's proper here - that which I thought would improve my condition and my chances of going back to sleep, served to worsen it and make sleep more unlikely. Good luck ashiwi, let's see if we can figure some option angles here.
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Post by otherottawaguy on Apr 7, 2014 7:40:53 GMT -5
Press Releases MannKind Updates Status of New Drug Application for AFREZZA(R) VALENCIA, Calif., April 7, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.
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Post by notamnkdmillionaire on Apr 7, 2014 12:35:08 GMT -5
Reading the PR from MNKD, it states "(FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests."
So what did the FDA request for MNKD to submit that the FDA didn't already have? Will we ever find out?
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Post by StevieRay on Apr 7, 2014 13:47:16 GMT -5
Hi Folks,
I wrote Matt and asked about the FDA Request and he responded. I’m not sure if my interpretation is correct but I feel better since it does not appear they are asking for additional information or new studies. They appear to be asking for information that has already been presented. They are probably still working through all the data and my guess is they are asking questions about the existing data. It’s not all that negative but still not very good either. I’m still hopeful this will get passed but I’m feeling very depressed.
My Email to Matt:
Hi Matt,
Sorry to keep bother you but shareholders deserve a little more transparency regarding the FDA “requests”. Please do the right thing and let everyone know the details of the FDA requests that was mentioned in the terse statement today:
“MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.”
Thanks, Steve
Matt’s Response:
Steve,
I believe that more detail around the requests, which were made and answered months ago, would not provide any information that would be helpful to investors and just as likely to be misleading as to be helpful.
Matt
My Response to Matt’s Response:
Hi Matt,
Thank you for responding. If I'm reading you correctly the FDA is asking for information which has already been provided. I believe this is not as severe as the Market believes. For myself I was thinking an additional study might be requested. So it is actually VERY helpful especially after being in the dark for such a very long time.
Thanks again for responding and keep up the great work. I'm very hopeful Afrezza will make it into the hands that need it the most.
Cheers, Steve
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Post by goyocafe on Apr 7, 2014 15:27:33 GMT -5
"Matt’s Response:
Steve,
I believe that more detail around the requests, which were made and answered months ago, would not provide any information that would be helpful to investors and just as likely to be misleading as to be helpful.
Matt"
From the sounds of it, FDA just added three months to continue their deliberation over information they already have; they haven't asked for anything new. Maybe they'll take the next six weeks to actually learn something about diabetes management and come to the same conclusion that a lot of us already have. Specifically that Afrezza actually controls prandial glucose excursions better than any other RAA. And hopefully they'll realize that their reliance on HBA1C as a sole determinating factor for the clinical utility of a diabetes drug is outdated and flawed. Maybe new trials in the future will include other primary end points such as Time in Range, Max glucose high, min glucose low, in addition to hba1c. They can then take the next six weeks to put together a stellar label that reflects their new found understanding and apprciation of this drug.
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Post by StevieRay on Apr 7, 2014 16:45:14 GMT -5
"Matt’s Response: Steve, I believe that more detail around the requests, which were made and answered months ago, would not provide any information that would be helpful to investors and just as likely to be misleading as to be helpful. Matt" From the sounds of it, FDA just added three months to continue their deliberation over information they already have; they haven't asked for anything new. Maybe they'll take the next six weeks to actually learn something about diabetes management and come to the same conclusion that a lot of us already have. Specifically that Afrezza actually controls prandial glucose excursions better than any other RAA. And hopefully they'll realize that their reliance on HBA1C as a sole determinating factor for the clinical utility of a diabetes drug is outdated and flawed. Maybe new trials in the future will include other primary end points such as Time in Range, Max glucose high, min glucose low, in addition to hba1c. They can then take the next six weeks to put together a stellar label that reflects their new found understanding and apprciation of this drug. I just wish they would just say hey, the FDA sent us the following.... and let the chips fall where they fall.
MannKind Management is skating on very thin ice and I'm just about fed up. For me I think it's better to sell at these levels than to buy into the unknown. We know for sure we have three more months and who know how many more shoes are going to fall off? Sorry to say this but I will be on the sidelines waiting for a better entry point. Sold out today and feel very bad but must protect my capital.
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Post by StevieRay on Apr 7, 2014 18:43:47 GMT -5
It would not surprise me if there was not a shoot out at the FDA over this....
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Post by BD on Apr 7, 2014 18:45:13 GMT -5
It would not surprise me if there was not a shoot out at the FDA over this.... So you're not expecting a shoot out? Or you're not not expecting a shoot out?
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Post by StevieRay on Apr 7, 2014 18:47:23 GMT -5
It would not surprise me if there was not a shoot out at the FDA over this.... So you're not expecting a shoot out? Or you're not not expecting a shoot out? I'm very sorry but can you parse those words for me.
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Post by StevieRay on Apr 7, 2014 18:52:13 GMT -5
It would not surprise me if there was not a shoot out at the FDA over this.... So you're not expecting a shoot out? Or you're not not expecting a shoot out? In other words I have very little to lose and I'm willing to send a message to the FDA.
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