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Post by saxcmann on Sept 12, 2016 10:51:58 GMT -5
Slides look to be the same as last time with the exception of updated stats on sales and the expectation that a submission for a label change is due this month. I'd like to know if the FDA has had any change in disposition toward MNKD in the past two years. If not, I have serious doubts they're going to make a label change very easy. Any idea how long the FDA usually takes to make a decision for a label change? November would be nice, yes? About 6 months.
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Post by peppy on Sept 12, 2016 10:54:00 GMT -5
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Post by od on Sept 12, 2016 10:57:37 GMT -5
Mnkd to advertise during MLB playoff games to reach 3 million people in q4 Really? That would be something! "Ad Placements" - Not necessarily broadcast.
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Post by peppy on Sept 12, 2016 11:01:52 GMT -5
Epi, time tables
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Post by kc on Sept 12, 2016 11:02:04 GMT -5
Great presentation by Matt and slide deck.
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Post by tayl5 on Sept 12, 2016 11:09:40 GMT -5
I liked Matt's confident tone. The plan is coming together.
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Post by b2011wilder on Sept 12, 2016 11:25:01 GMT -5
Epi, time tables Doesn't that slide suggest that an inhaled drug would be inappropriate? "Wheezing, shortness of breath, swelling of...pharynx"?
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Post by goyocafe on Sept 12, 2016 11:26:41 GMT -5
Epi, time tables Doesn't that slide suggest that an inhaled drug would be inappropriate? "Wheezing, shortness of breath, swelling of...pharynx"? Ask an asthmatic...
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Post by peppy on Sept 12, 2016 11:34:28 GMT -5
Epi, time tables Doesn't that slide suggest that an inhaled drug would be inappropriate? "Wheezing, shortness of breath, swelling of...pharynx"? Those are the symptoms: Wheezing, shortness of breath, swelling of...pharynx. The symptoms tell you, I need intervention.
Afrezza epi, is the intervention. Quick as can be. delivered to the site. stopping the spasm. allowing relaxation. allowing breathe.
Couldn't be a better set up.
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Post by centralcoastinvestor on Sept 12, 2016 11:37:02 GMT -5
I did not get to listen. Was bridge financing discussed?
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Post by boomboom on Sept 12, 2016 11:37:53 GMT -5
It is great we have a window of opportunity to inhale; however, my follow up question would be..."How quickly do people recognize that they are having a severe attack?" I know people with severe allergies that observe the symptoms mentioned in the window above that attribute these symptoms to being "no big deal" and that it will pass. No one wants to inject themselves immediately without assessing the situation for several minutes. I doubt anyone would take a dose of epinephrine within the first 10 minutes and even more so if they have never experienced an attack before.
Thoughts?
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Post by peppy on Sept 12, 2016 11:39:20 GMT -5
I did not get to listen. Was bridge financing discussed? mentioned it was a referral to the may financing that was done.
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Post by rayskum on Sept 12, 2016 11:40:25 GMT -5
My son has many food allergies. He will tell us in 30 sec about tingling sensation if the food got contaminated for whatever reason
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Post by peppy on Sept 12, 2016 11:44:05 GMT -5
It is great we have a window of opportunity to inhale; however, my follow up question would be..." How quickly do people recognize that they are having a severe attack?" I know people with severe allergies that observe the symptoms mentioned in the window above that attribute these symptoms to being "no big deal" and that it will pass. No one wants to inject themselves immediately without assessing the situation for several minutes. I doubt anyone would take a dose of epinephrine within the first 10 minutes and even more so if they have never experienced an attack before. Thoughts? Answer, pretty darn quick when it is your airway. We breathe 10 to 20 times a minute. (Adult)
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Post by boomboom on Sept 12, 2016 11:44:24 GMT -5
Do you administer epinephrine after that 30 seconds?
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