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Post by orlon on Apr 30, 2017 23:02:59 GMT -5
Someone posted a few weeks ago that the FDA has to approve the advertisement for a drug before it is released to the public. According to the FDA website, this is NOT the case. Just thought I'd clarify for those waiting for FDA approval....could be a long wait.
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Post by scoy on Apr 30, 2017 23:16:10 GMT -5
I posted this link before. This is what the FDA says. I believe most companies run their ads by the FDA before they go to the expense of running them. Does the FDA review and approve all advertisements for drugs before their release? No. In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used. We see many ads at about the same time the public sees them. Many drug companies voluntarily seek advice from us before they release TV ads. However, if we believe that an ad violates the law, we send a letter to the drug company asking that the ads be stopped right away. www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072077.htm
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Post by tiberious on May 1, 2017 8:29:45 GMT -5
Its time to release whatever advertisements they may have. Mannkind management and BOD have tried everything else and look at where we are now. Mike's sentiment that a TV commercial is money wasted, while sounding reasoned, is a clearly big MISTAKE when compared to the huge Mannkind market cap loss since Mike taking the helm. The medical establishment will not push for or advocate for a better innovative treatment this is now sadly clear. The PATIENT needs to drive demand here. Think MY PILLOW commercial. Think UnTuckIT shirt commercial. Think for Pete's sake! Other BP advertise their product but we don't... go figure. Oh and P.S. Mike... a deal with any other country would do wonders for script count wouldn't it? Bulk shipments of I don't know lets say 300k boxes to a MENA country what would that do for script counts Mike and team?
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Post by Cowgirl on May 1, 2017 8:36:52 GMT -5
Please....Matt&Mike...(and Al Mann for that matter) all know exactly how big Afrezza will be. They have everything under control and know exactly how to create a pharma sales company. But we know where that has got us. The bigger problem here is mannkind has NO MONEY to even run commercials!. They need every dime just to continue to stay open for 6 more months. If they throw 5-10 million on tv - it's gone and there is not enough time to have a script impact. That why share price is at .17 cents pre-split!
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Post by factspls88 on May 1, 2017 8:47:04 GMT -5
Mike C said that the commercial is with the FDA for approval. That should be enough confirmation that this is happening. When I was in the consumer products business, every commercial had to be approved by internal legal and the networks to ensure that claims were supported by data, so this is no surprise to me re mnkd.
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Post by gamblerjag on May 1, 2017 9:15:18 GMT -5
Matt said that the commercial is with the FDA for approval. That should be enough confirmation that this is happening. When I was in the consumer products business, every commercial had to be approved by internal legal and the networks to ensure that claims were supported by data, so this is no surprise to me re mnkd. perhaps the need for fda approval is needed because it coincides with a clean label. Maybe we will get a 1-2 punch here ?
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Post by Cowgirl on May 1, 2017 9:22:00 GMT -5
Matt said that the commercial is with the FDA for approval. That should be enough confirmation that this is happening. When I was in the consumer products business, every commercial had to be approved by internal legal and the networks to ensure that claims were supported by data, so this is no surprise to me re mnkd. perhaps the need for fda approval is needed because it coincides with a clean label. Maybe we will get a 1-2 punch here ? Well...like technosphere for pain & cancer, EPI, RLS, int'l partner, large Mid East buyer, VDex, contract sales force expertise, low margin but at least foreign sales to help pay for Danbury, scripts are building, google/IBM watson, Paul Allen/Howard Schwartz etc. etc. etc. it COULD be....but most likely another Aerosmith on that - DREAM ON! DREAM ON! They'll be asking for interest/buyers at next conf call but they also will have forgotten that they've put the speaker on mute as to not take any critical questions so they'll miss out on Larry Page calling in!
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Post by akemp3000 on May 1, 2017 9:46:38 GMT -5
perhaps the need for fda approval is needed because it coincides with a clean label. Maybe we will get a 1-2 punch here ? Well...like technosphere for pain & cancer, EPI, RLS, int'l partner, large Mid East buyer, VDex, contract sales force expertise, low margin but at least foreign sales to help pay for Danbury, scripts are building, google/IBM watson, Paul Allen/Howard Schwartz etc. etc. etc. it COULD be....but most likely another Aerosmith on that - DREAM ON! DREAM ON! They'll be asking for interest/buyers at next conf call but they also will have forgotten that they've put the speaker on mute as to not take any critical questions so they'll miss out on Larry Page calling in! Hahaha...see Journey - DON'T STOP BELIEVIN!
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Post by madog365 on May 1, 2017 9:56:10 GMT -5
Used to work in pharma advertising and ads take about 6 months for approval ... I'm not sure if it's required but pretty much all pharma companies consult with FDA and submit for their approval. Also if you know Mannkind, you know they are ultra conservative with absolutely everything they do so they are waiting for the FDA to get the go ahead. it should happen this month or by June.
Personally i don't agree with their approach, this is the time to take risks but maybe they see it differently for reasons unknown.
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Post by Cowgirl on May 1, 2017 10:01:54 GMT -5
Used to work in pharma advertising and ads take about 6 months for approval ... I'm not sure if it's required but pretty much all pharma companies consult with FDA and submit for their approval. Also if you know Mannkind, you know they are ultra conservative with absolutely everything they do so they are waiting for the FDA to get the go ahead. it should happen this month or by June. Personally i don't agree with their approach, this is the time to take risks but maybe they see it differently for reasons unknown. Ok...so say we FINALLY have a commercial approved in June. Then what, it needs to run - certainly a few times. Great. Hey, now there are some people who didn't know about Afrezza. Say they are even diabetics. They call their Endo to get an appointment or plan to ask at their regularly scheduled appt. That can take 6 months! Then, samples, trying it out - tweeking. So, even IF they run a few commercials AND it instigates some inquiries we are looking at year end or beyond before it could be deemed to have had an impact. In the mean time we wait for reality show - reversed - and then watch the big DUD that happens after that. Mannkind needs a large pharma buyer/marketer with deep pockets for the long run as this will take time.
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Post by hammer on May 1, 2017 10:04:23 GMT -5
I just had the opportunity to speak with 2 new physicians. one starting an internal med residency the other anesthesiology. I asked them if the have ever heard of Afrezza. Imagine my disbelief when neither were aware. I did provide them with a quick inservice. Happenned to have the inhaler in my pocket to show them. This is failure on mnkd's part since reps should be providing some sort of inservice at teaching institutions. Its is an ideal drug for use in association with cgm and those most in tune to new drugs are still not aware.
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Post by tiberious on May 1, 2017 10:33:14 GMT -5
I just had the opportunity to speak with 2 new physicians. one starting an internal med residency the other anesthesiology. I asked them if the have ever heard of Afrezza. Imagine my disbelief when neither were aware. I did provide them with a quick inservice. Happenned to have the inhaler in my pocket to show them. This is failure on mnkd's part since reps should be providing some sort of inservice at teaching institutions. Its is an ideal drug for use in association with cgm and those most in tune to new drugs are still not aware. Hence the need for TV Ads. See my suggestion above. Whatever they are doing IS NOT WORKING! Demand needs to come from the PATIENT! Time to put down the the sales push Kool Aid and get the product in front of the eyes of the consumer.
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Post by careful2invest on May 1, 2017 11:03:26 GMT -5
Matt said that the commercial is with the FDA for approval. That should be enough confirmation that this is happening. When I was in the consumer products business, every commercial had to be approved by internal legal and the networks to ensure that claims were supported by data, so this is no surprise to me re mnkd. perhaps the need for fda approval is needed because it coincides with a clean label. Maybe we will get a 1-2 punch here ? Short of an infusion of cash from somewhere, this would be great news!
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Post by porkini on May 1, 2017 11:05:27 GMT -5
I just had the opportunity to speak with 2 new physicians. one starting an internal med residency the other anesthesiology. I asked them if the have ever heard of Afrezza. Imagine my disbelief when neither were aware. I did provide them with a quick inservice. Happenned to have the inhaler in my pocket to show them. This is failure on mnkd's part since reps should be providing some sort of inservice at teaching institutions. Its is an ideal drug for use in association with cgm and those most in tune to new drugs are still not aware. I would like to "happen to have the inhaler in my pocket" to share when the opportunity arises. Any thoughts on how someone who is not a PWD and does not have a prescription might obtain a couple inhalers?
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Post by slugworth008 on May 1, 2017 11:10:32 GMT -5
I just had the opportunity to speak with 2 new physicians. one starting an internal med residency the other anesthesiology. I asked them if the have ever heard of Afrezza. Imagine my disbelief when neither were aware. I did provide them with a quick inservice. Happenned to have the inhaler in my pocket to show them. This is failure on mnkd's part since reps should be providing some sort of inservice at teaching institutions. Its is an ideal drug for use in association with cgm and those most in tune to new drugs are still not aware. Hence the need for TV Ads. See my suggestion above. Whatever they are doing IS NOT WORKING! Demand needs to come from the PATIENT! Time to put down the the sales push Kool Aid and get the product in front of the eyes of the consumer. Absolutely spot on!
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