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Post by BlueCat on Oct 2, 2017 23:01:22 GMT -5
Hail Proboardians -
Q Lurking from under the rubble.
Please forgive - I've read some of the threads here, the news coverage and the press release.
Does someone have the quick-to-explain answer on why just "Rapid" and not "Ultra rapid" like Fiasp?
If there is a post that's covered this already, link away - I can read!
-Q
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Post by cretin11 on Oct 2, 2017 23:02:32 GMT -5
Hail Proboardians - Q Lurking from under the rubble. Please forgive - I've read some of the threads here, the news coverage and the press release. Does someone have the quick-to-explain answer on why just "Rapid" and not "Ultra rapid" like Fiasp? If there is a post that's covered this already, link away - I can read! -Q i don't think Fiasp got "ultra rapid" did they? |
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Post by BlueCat on Oct 2, 2017 23:09:42 GMT -5
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Post by dreamboatcruise on Oct 2, 2017 23:39:57 GMT -5
You can also find references to Afrezza as ultra-rapid or ultra-fast. The FDA, however, has not created a new designation. Neither one got that from FDA. Apparently FDA is waiting for a process involving ADA and JDRF to come up with some guideline as to what should qualify for a new designation if one is created. Fiasp was first approved in Canada and Novo put out PR material calling it ultra-fast... but I don't even believe that was something the Canadian drug regulatory body approved (it doesn't seem to be in package insert material). It may be because of this early PR from Novo that more coverage seems to include that term. They might have run afoul of FDA if they'd done that as part of the PR about approval here in US. |
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Post by BlueCat on Oct 2, 2017 23:46:23 GMT -5
You can also find references to Afrezza as ultra-rapid or ultra-fast. The FDA, however, has not created a new designation. Neither one got that from FDA. Apparently FDA is waiting for a process involving ADA and JDRF to come up with some guideline as to what should qualify for a new designation if one is created. Fiasp was first approved in Canada and Novo put out PR material calling it ultra-fast... but I don't even believe that was something the Canadian drug regulatory body approved (it doesn't seem to be in package insert material). It may be because of this early PR from Novo that more coverage seems to include that term. They might have run afoul of FDA if they'd done that as part of the PR about approval here in US. Seems Novo wants it to be represented that way - under the "About Fiasp" section at bottom. |
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Post by dreamboatcruise on Oct 3, 2017 0:02:34 GMT -5
You can also find references to Afrezza as ultra-rapid or ultra-fast. The FDA, however, has not created a new designation. Neither one got that from FDA. Apparently FDA is waiting for a process involving ADA and JDRF to come up with some guideline as to what should qualify for a new designation if one is created. Fiasp was first approved in Canada and Novo put out PR material calling it ultra-fast... but I don't even believe that was something the Canadian drug regulatory body approved (it doesn't seem to be in package insert material). It may be because of this early PR from Novo that more coverage seems to include that term. They might have run afoul of FDA if they'd done that as part of the PR about approval here in US. Seems Novo wants it to be represented that way - under the "About Fiasp" section at bottom. Wanted, but they will not be allowed to do so in marketing materials or adverts in the US. |
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Post by buyitonsale on Oct 3, 2017 0:04:05 GMT -5
Listened to cc again and encourage others to do
the same, I always pickup new nuances as the
expectations are no longer a factor.
Mike is very articulate about Afrezza and label information.
He seems to be very happy about the outcome.
The warrants development is part posturing and part
planning for the upcoming recapitalization announcement.
I think it’s smart to have a way out in case things do not go
your way.... CFO was very brief and to the point, I like
his style.
Longs will win.
Go MNKD!
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