|
|
Post by goyocafe on Jan 7, 2019 11:36:01 GMT -5
Looks to me like we need large trial data proving Afrezza superior.. more label change and freedom to say what Afrezza does.. and a merger or partnership with Vdex.. and then change the SOC .. how long and how much money? As far as the SOC is concerned, my guess is years to never. They won’t even acknowledge Afrezza as an equal to its peers. That tells me everything about the ADA and it’s allegiance to BP. |
|
|
|
Post by sweedee79 on Jan 7, 2019 11:43:34 GMT -5
Looks to me like we need large trial data proving Afrezza superior.. more label change and freedom to say what Afrezza does.. and a merger or partnership with Vdex.. and then change the SOC .. how long and how much money? As far as the SOC is concerned, my guess is years to never. They won’t even acknowledge Afrezza as an equal to its peers. That tells me everything about the ADA and it’s allegiance to BP. If that is the case then what hope do we have and/or what is Mike's plan? They have talked about changing the SOC .. what's their plan? That's what I want to know.. |
|
|
|
Post by InvesterSam on Jan 7, 2019 12:01:01 GMT -5
Looks to me like we need large trial data proving Afrezza superior.. more label change and freedom to say what Afrezza does.. and a merger or partnership with Vdex.. and then change the SOC .. how long and how much money? As far as the SOC is concerned, my guess is years to never. They won’t even acknowledge Afrezza as an equal to its peers. That tells me everything about the ADA and it’s allegiance to BP. I believe SOC change by ADA is data driven. MNKD needs to present well-designed trial data. |
|
|
|
Post by goyocafe on Jan 7, 2019 12:07:14 GMT -5
As far as the SOC is concerned, my guess is years to never. They won’t even acknowledge Afrezza as an equal to its peers. That tells me everything about the ADA and it’s allegiance to BP. If that is the case then what hope do we have and/or what is Mike's plan? They have talked about changing the SOC .. what's their plan? That's what I want to know.. It's just my opinion, but I get the impression they (MNKD) really don't want to talk about the elephant in the room. Mike was giving themselves praise for the latest SOC updates, when really it only changed the language of existing references to reflect the label and to some degree the STAT study. I would be really impressed if the ADA were to include Afrezza as part of the recommended protocol (whenever other injectable meal time insulin is recommended). That would show the ADA is being inclusive of all possible remedies with similar demonstrated therapeutic benefits. MNKD won't talk about what is needed for that to happen, if anything. They may already know that the ADA is biased and they're just grateful for the cameo appearance. If you want to talk about instant exposure. Every endo in the country would see that and take notice. |
|
|
|
Post by goyocafe on Jan 7, 2019 12:10:02 GMT -5
As far as the SOC is concerned, my guess is years to never. They won’t even acknowledge Afrezza as an equal to its peers. That tells me everything about the ADA and it’s allegiance to BP. I believe SOC change by ADA is data driven. MNKD needs to present well-designed trial data. The FDA has already given Afrezza a label that indicates it is "non-inferior" to other meal time insulin. What data are you suggesting they need to generate? |
|
|
|
Post by mango on Jan 7, 2019 12:11:37 GMT -5
I don't disagree sweedie, but FDA has been rolling out the Real World Data and Real World Evidence guidance and that's something MannKind needs to use to their full advantage.
SoC is doing what is best for ADA and the drug companies that it caters to, not what is best for the patients.
Looking at the SoC there's no indication, as far as I can see, of ADA trying to treat diabetes the medically correct way, much less in a safe way. The SoC looks like a milk pipeline, and its gotten out of control, just look at it!
You look at GLP-1s and SGLT-2 ls and they carry so much serious potential irreversible harm, the benefits in no logical way out-weight the risks...they're chit.
Those that have the keys to the SoC appear to not want anything to do with Afrezza in any way, nor does there appear to be any interest among the Endo Consensus regarding its potential.
Amputations, tumors, cancers, amyloidosis, gangrene, etc...it doesn't matter what horrible new thing happens tomorrow, they will ignore it. We even have FDA Commissioner Scott Gottlieb calling out Sanofi, Novo and Lilly for their unethical and unmoral practices, it's criminal!
These companies have been charged by DoJ for illegal practices, particularly Novo. They are in it for themselves and right now they are the ones controlling the turf. You know chit has hit the fan when the FDA Commissioner outs them on both Twitter and in official press releases.
|
|
|
|
Post by madog365 on Jan 7, 2019 12:25:26 GMT -5
heavy? No. Hey, longs, that's the kind of baloney we're going to hear for the next two months! So just ignore that the company ran commercials for the past few months? If the commercial works as the company says, than we should continue to see impact on scripts all throughout Jan and Feb. Why would you wait 8 weeks after the commercials restart? This is ridiculous, no more moving the goal posts. I've been in this way too long to keep hearing 8 weeks away. |
|
|
|
Post by ilovekauai on Jan 7, 2019 12:28:05 GMT -5
My two cents: IMO, SOC, is Dr. David Kendall's realm. We haven't heard anything from him lately. I hope he is worth the money because it was a big, big, deal when he was hired. It would be really great to get an update from him on what progress he's made in the past year since coming on board last Spring. If we don't hear from Dr. Kendall before the ASM this May, it really needs to be a topic of discussion and a full report really must be forthcoming. Thank you.
|
|
|
|
Post by mannmade on Jan 7, 2019 12:52:55 GMT -5
As I recall Aaron Kowalski, the chief mission officer for the jdrf used to use afrezza (and may still) for corrections. He is a scientist, am not sure why he has not spoken up more about afrezza having tried it and at least inially like it.
|
|
|
|
Post by goyocafe on Jan 7, 2019 12:54:25 GMT -5
As I recall Aaron Kowalski, the chief mission officer for the jdrf used to use afrezza (and may still) for corrections. He is a scientist, am not sure why he has not spoken up more about afrezza having tried it and at least inially like it. Just ask yourself who funds them, you’ll have your answer. |
|
|
|
Post by sweedee79 on Jan 7, 2019 13:05:45 GMT -5
If that is the case then what hope do we have and/or what is Mike's plan? They have talked about changing the SOC .. what's their plan? That's what I want to know.. It's just my opinion, but I get the impression they (MNKD) really don't want to talk about the elephant in the room. Mike was giving themselves praise for the latest SOC updates, when really it only changed the language of existing references to reflect the label and to some degree the STAT study. I would be really impressed if the ADA were to include Afrezza as part of the recommended protocol (whenever other injectable meal time insulin is recommended). That would show the ADA is being inclusive of all possible remedies with similar demonstrated therapeutic benefits. MNKD won't talk about what is needed for that to happen, if anything. They may already know that the ADA is biased and they're just grateful for the cameo appearance. If you want to talk about instant exposure. Every endo in the country would see that and take notice. It appears to me that we better start talking about and addressing the elephant in the room.. Afrezza is a gold mine.. time to strike gold.. it would be a shame if PWD never had the opportunity to really know Afrezza.. Vdex understands this. At the rate we are going and with still so many obstacles we may need to go around them.. advertise and hook up with Vdex. Fk the.endos (sorry, I don't like this BS) |
|
|
|
Post by sportsrancho on Jan 7, 2019 13:11:28 GMT -5
Target the 10 largest states by population: California 39 million Texas 28 million Florida 21 million New York 20 million Illinois 13 million Pennsylvania 13 million Ohio 12 million Georgia 10 million N. Carolina 10 million Michigan 10 million
These ten states make up almost half the population of the US. I want thousands of prescriptions not tens. You have to target by media market - i.e. where the ads are able to run. DMAs posted by nylefty delineate them. I built a national brand by starting out in select DMAs and expanded to more of them as the business grew until ultimately it was more cost effective to use national rather than local advertising. I'm glad to see Mike is doing the same. Good to hear. You’re one of the people whose opinion I trust the most, ever since the Yahoo days:-) I’m hoping to build back my faith in management over the next three months. |
|
|
|
Post by goyocafe on Jan 7, 2019 13:12:23 GMT -5
It's just my opinion, but I get the impression they (MNKD) really don't want to talk about the elephant in the room. Mike was giving themselves praise for the latest SOC updates, when really it only changed the language of existing references to reflect the label and to some degree the STAT study. I would be really impressed if the ADA were to include Afrezza as part of the recommended protocol (whenever other injectable meal time insulin is recommended). That would show the ADA is being inclusive of all possible remedies with similar demonstrated therapeutic benefits. MNKD won't talk about what is needed for that to happen, if anything. They may already know that the ADA is biased and they're just grateful for the cameo appearance. If you want to talk about instant exposure. Every endo in the country would see that and take notice. It appears to me that we better start talking about and addressing the elephant in the room.. Afrezza is a gold mine.. time to strike gold.. it would be a shame if PWD never had the opportunity to really know Afrezza.. Vdex understands this. At the rate we are going and with still so many obstacles we may need to go around them.. advertise and hook up with Vdex. Fk the.endos (sorry, I don't like this BS) I agree 100%. I think vdexdiabetes said it right, or was it mnholdem. Time for the nuclear option. Call the whole corrupt system to the carpet. Get on the talk shows, 60 minutes; call out individuals too afraid to stand up for the patient; call out the ADA. |
|
|
|
Post by sportsrancho on Jan 7, 2019 13:13:49 GMT -5
It's just my opinion, but I get the impression they (MNKD) really don't want to talk about the elephant in the room. Mike was giving themselves praise for the latest SOC updates, when really it only changed the language of existing references to reflect the label and to some degree the STAT study. I would be really impressed if the ADA were to include Afrezza as part of the recommended protocol (whenever other injectable meal time insulin is recommended). That would show the ADA is being inclusive of all possible remedies with similar demonstrated therapeutic benefits. MNKD won't talk about what is needed for that to happen, if anything. They may already know that the ADA is biased and they're just grateful for the cameo appearance. If you want to talk about instant exposure. Every endo in the country would see that and take notice. It appears to me that we better start talking about and addressing the elephant in the room.. Afrezza is a gold mine.. time to strike gold.. it would be a shame if PWD never had the opportunity to really know Afrezza.. Vdex understands this. At the rate we are going and with still so many obstacles we may need to go around them.. advertise and hook up with Vdex. Fk the.endos (sorry, I don't like this BS) And this right here is the bottom line, absolutely agree! |
|
|
|
Post by wsulylecoug on Jan 7, 2019 13:56:24 GMT -5
It's just my opinion, but I get the impression they (MNKD) really don't want to talk about the elephant in the room. Mike was giving themselves praise for the latest SOC updates, when really it only changed the language of existing references to reflect the label and to some degree the STAT study. I would be really impressed if the ADA were to include Afrezza as part of the recommended protocol (whenever other injectable meal time insulin is recommended). That would show the ADA is being inclusive of all possible remedies with similar demonstrated therapeutic benefits. MNKD won't talk about what is needed for that to happen, if anything. They may already know that the ADA is biased and they're just grateful for the cameo appearance. If you want to talk about instant exposure. Every endo in the country would see that and take notice. It appears to me that we better start talking about and addressing the elephant in the room.. Afrezza is a gold mine.. time to strike gold.. it would be a shame if PWD never had the opportunity to really know Afrezza.. Vdex understands this. At the rate we are going and with still so many obstacles we may need to go around them.. advertise and hook up with Vdex. Fk the.endos (sorry, I don't like this BS) I hit the thumbs up button 20 times or more...but it wasn't working right...  How do we get the Vdex results widely into mainstream media? |
|
