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Post by boca1girl on Feb 27, 2020 9:41:07 GMT -5
Hmm can't find it. In my own defense I am deaf in one ear so, yeah obviously misheard him ☹️ Marketing person. See my post above. |
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Post by mnholdem on Feb 27, 2020 9:45:36 GMT -5
I'll go back and listen later today, I'm 99% sure he said that. It's in the Q&A session: Steven Michael Lichtman, Oppenheimer & Co. Inc., Research Division - MD and Senior Analyst - "Mike, can you talk a little bit more about how you're evaluating the pediatric opportunity, as you mentioned? Just curious on your areas of focus and the milestones ahead on that."
Michael E. Castagna, MannKind Corporation - CEO & Director - So on the pediatric, I mean we were very excited to get alignment with FDA directionally on finalization of the part 1 of the 2 parts for approval. Part 1 was just confirming that our PK results meet the criteria for the FDA for the 8- to 17-year olds. And then the second part of that alignment with FDA was that we're going to forgo a 4- to 7-year-old label indication, and they've aligned directionally to those 2 requests...
- The next part is getting the Phase III study protocol approved. That will happen over the next 3 to 6 months. And then in that time frame, we'll be meeting with many of the thought leaders...
- And then the final is just the whole market assessment needs, and we really believe that -- my personal bias is that the way you change the standard of care for the next 100 years is really through pediatrics and type 1 and getting these patients started in early age, getting them to get great outcomes, proper dosing will grow up on the product, they'll transition to adult endos, there's teenagers into college, some more kids growing up, they may never have to experience an injectable mealtime insulin or a pump for that matter. So we think that's the big opportunity, to start to lay out that foundation, and we'll confirm that through our market assessments that we're doing or we're conducting as we speak. ...looking to hire a dedicated marketer to lead that up as well as a PH Endocrinologist. So we're really going to start to focus our efforts to make sure we do a great job in the pediatric segment. And we think it's a big opportunity, but we'll confirm that through additional research.
I have no idea what a "PH" Endocrinologist is but that could simply been an erroneously-reported transcript. |
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Post by mango on Feb 27, 2020 9:51:54 GMT -5
I'll go back and listen later today, I'm 99% sure he said that. It's in the Q&A session: Steven Michael Lichtman, Oppenheimer & Co. Inc., Research Division - MD and Senior Analyst - "Mike, can you talk a little bit more about how you're evaluating the pediatric opportunity, as you mentioned? Just curious on your areas of focus and the milestones ahead on that."
Michael E. Castagna, MannKind Corporation - CEO & Director - So on the pediatric, I mean we were very excited to get alignment with FDA directionally on finalization of the part 1 of the 2 parts for approval. Part 1 was just confirming that our PK results meet the criteria for the FDA for the 8- to 17-year olds. And then the second part of that alignment with FDA was that we're going to forgo a 4- to 7-year-old label indication, and they've aligned directionally to those 2 requests...
- The next part is getting the Phase III study protocol approved. That will happen over the next 3 to 6 months. And then in that time frame, we'll be meeting with many of the thought leaders...
- And then the final is just the whole market assessment needs, and we really believe that -- my personal bias is that the way you change the standard of care for the next 100 years is really through pediatrics and type 1 and getting these patients started in early age, getting them to get great outcomes, proper dosing will grow up on the product, they'll transition to adult endos, there's teenagers into college, some more kids growing up, they may never have to experience an injectable mealtime insulin or a pump for that matter. So we think that's the big opportunity, to start to lay out that foundation, and we'll confirm that through our market assessments that we're doing or we're conducting as we speak. ...looking to hire a dedicated marketer to lead that up as well as a PH Endocrinologist. So we're really going to start to focus our efforts to make sure we do a great job in the pediatric segment. And we think it's a big opportunity, but we'll confirm that through additional research.
I have no idea what a "PH" Endocrinologist is but that could simply been an erroneously-reported transcript. I bet it is a typo and he said Pediatric Endocrinologist. SA is known for having numerous typos in their transcripts. Anyone want to go back and listen to that Q&A section to verify? |
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Post by porkini on Feb 27, 2020 10:23:37 GMT -5
It's in the Q&A session: Steven Michael Lichtman, Oppenheimer & Co. Inc., Research Division - MD and Senior Analyst - "Mike, can you talk a little bit more about how you're evaluating the pediatric opportunity, as you mentioned? Just curious on your areas of focus and the milestones ahead on that."
Michael E. Castagna, MannKind Corporation - CEO & Director - So on the pediatric, I mean we were very excited to get alignment with FDA directionally on finalization of the part 1 of the 2 parts for approval. Part 1 was just confirming that our PK results meet the criteria for the FDA for the 8- to 17-year olds. And then the second part of that alignment with FDA was that we're going to forgo a 4- to 7-year-old label indication, and they've aligned directionally to those 2 requests...
- The next part is getting the Phase III study protocol approved. That will happen over the next 3 to 6 months. And then in that time frame, we'll be meeting with many of the thought leaders...
- And then the final is just the whole market assessment needs, and we really believe that -- my personal bias is that the way you change the standard of care for the next 100 years is really through pediatrics and type 1 and getting these patients started in early age, getting them to get great outcomes, proper dosing will grow up on the product, they'll transition to adult endos, there's teenagers into college, some more kids growing up, they may never have to experience an injectable mealtime insulin or a pump for that matter. So we think that's the big opportunity, to start to lay out that foundation, and we'll confirm that through our market assessments that we're doing or we're conducting as we speak. ...looking to hire a dedicated marketer to lead that up as well as a PH Endocrinologist. So we're really going to start to focus our efforts to make sure we do a great job in the pediatric segment. And we think it's a big opportunity, but we'll confirm that through additional research.
I have no idea what a "PH" Endocrinologist is but that could simply been an erroneously-reported transcript. I bet it is a typo and he said Pediatric Endocrinologist. SA is known for having numerous typos in their transcripts. Anyone want to go back and listen to that Q&A section to verify? Working on finding the audio mark... Steven Lichtman questions begin at 39:36 in the webcast ( viavid.webcasts.com/viewer/event.jsp?ei=1277129&tp_key=3637b14323) The MC comments about the last bullet point start at 41:39 The transcripts may have been covered in monkey poop peppy and MC did say "hire a dedicated marketer... as well as a pediatric endocrinologist" Here is the quoted SA transcript of the last bullet point that I found: |
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Post by peppy on Feb 27, 2020 10:41:31 GMT -5
I bet it is a typo and he said Pediatric Endocrinologist. SA is known for having numerous typos in their transcripts. Anyone want to go back and listen to that Q&A section to verify? Working on finding the audio mark... Steven Lichtman questions begin at 39:36 in the webcast ( viavid.webcasts.com/viewer/event.jsp?ei=1277129&tp_key=3637b14323) The MC comments about the last bullet point start at 41:39 The transcripts may have been covered in monkey poop peppy and MC did say "hire a dedicated marketer... as well as a pediatric endocrinologist" Here is the quoted SA transcript of the last bullet point that I found: I did my part!  |
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Post by brotherm1 on Feb 27, 2020 10:44:15 GMT -5
I wouldn’t blame SA for any typos, MC is infamous for mumbling-fast-talk.
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Post by Deleted on Feb 27, 2020 11:04:42 GMT -5
What is it about the physicians/clinics that makes the Top 10 Afrezza writers so successful? MannKind's Chief Medical Officer SHOULD be paying attention to these endocrinologists. They may possess some of the answers needed to win greater adoption for Afrezza. Frankly, if he isn't already, Dr. Kendall should also make the time to "hob nob" with Vdex doctors. Frankly, pguererro's commentary about what Dr Kendall's activities consist of is simply not credible, although I would like to see a larger, more visible role for the CMO.  I may have misheard MC on the CC, but I swear I thought he mentioned they were in the process of hiring a Pediatric Endocrinologist. Anyone catch that? Yes he said that. They need additional expertise to make sure they do the PEDS Trial right the first time. There is NO ROOM FOR ERROR THIS TIME. |
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Post by Deleted on Feb 27, 2020 11:06:59 GMT -5
Even 8 inhalations a day is not a treatment burden, IMO. It is a painless, very quick process from start to finish loading a cartridge and inhaling the insulin. If the excuse is "I don't have time to inhale 8 times a day," then I argue well you have to MAKE TIME. You make time to go shopping, you make time to have yard of the month, you make time to get on social media, you make time to watch TV, you make time to wash your car, you make time to clean your car, and on and on...you have to MAKE TIME for you health! You can't ever expect to live as a non-diabetic or close to non-diabetic if you are not willing to make time for your health. If you refuse to make time to inhale a couple of times per meal then you obviously have other issues. All in my opinion of course. You gotta make time, you're always going to be leaving your car, you're always going to be leaving your house, you're always going to be leaving your yard...you'll never be leaving your body while you are alive so make time! But, that's just mango'stakeonit Like Donna said.....it's like a HELIUM Balloon...when you see your CGM rising....You take Afrezza. So it really depends on your body and the foods you eat. |
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Post by mango on Feb 27, 2020 11:11:40 GMT -5
I wouldn’t blame SA for any typos, MC is infamous for mumbling-fast-talk. That's a really lame jab. Did we run out of 410 today or just full of hate? |
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Post by rockstarrick on Feb 27, 2020 12:15:03 GMT -5
Pguerro from what I understand either works for mnkd or did.. this is information we at least need to consider.. There are reasons that Afrezza sales have been so low.. it's about time for people to wake up. I suggest you pay attention to what Sports has been trying so hard to tell us.. I'm not sure I agree with everything that pguerro says as I believe Afrezza is the best for type 1 and 2.. but convincing the market of this at our price point with out the trial data to back it up is another matter. I also believe our CEO has been less than honest about the situation. Yes, no disrespect, but current employee, former employee, disgruntled?, maybe overlooked for a higher position?, I mean c’mon, why in the hell would any investor make investment decisions off of remark from anybody on a message board. I know for fact that Afrezza works, and those that use it, love it. And to a certain extent, I disagree with why retention in slow. People aren’t staying on Afrezza because of lack of coverage and out of pocket cost. If it was affordable our retention would be as good as any competitors. Get better coverage or make it affordable and we’ll be golden. We need volume,!! Who cares if retention is 50% or 80% if you aren’t selling, it’s a bigger % of nothing. Lower the price, get it covered, it’s not rocket science. |
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Post by rockstarrick on Feb 27, 2020 12:18:46 GMT -5
There are so many naive comments on this site regarding real world choices for today’s doctor and treating diabetes I stopped righting down notes on who to respond to and how. I started this by telling u a fact. U guys haven’t talked to multiple patients and multiple prescribers about Afrezza. Hell double down on your investment. Mike will spin a new thread at the next big conference. Also, VDEX Is a losing proposition as well (sorry Sports). It’s Afrezza Don't know how you can simply say "it's Afrezza".. I have had real world experience.. and it's been entirely positive.. You had my ear right up until now. You sound like a closed minded basher. Are you a sales rep with Mnkd? Again, we’ve all worked with “that guy”. Opinions vary, I respectfully disagree with this employee. |
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Post by rockstarrick on Feb 27, 2020 12:34:51 GMT -5
From Steve.... Stephen Brown Vice president Vdex diabetes Real simple math... 350(avg new patients per week)X 52 (wks in yr) =18,200 x 4yrs= 72,800 patients. (Approximate) MNKD says there are 5-6k patients now. 7280 patients would speak to a drop rate of over 90%. Simple And that is not subtracting those patients that were in the trials and stayed and those from Sanofi. They can't sell Afrezza because of all the things he/she is saying, which we have all discussed before. Drs are not putting T2s on insulin or anyone else when they have another choice. VDEX trains/educates this out of it's providers. Al made this for Everyone! Especially T2s. Afrezza works like a dream on all types!!! VDEX sees T1s/T2s at around the national averages...7% vs 93%. (snip) SDB I'm a VDEX supporter, but Steve is wrong about the number of "new patients" on Afrezza. The 350 average NRx number is for new scripts, not new patients. MC says that only about 25 percent of the "new" prescriptions are for new patients. Assuming that's true, the rest are for dosage changes and yearly renewals. Our last script report trx = 782 nrx = 301 rrx = 481 nrx = 25% actual (301)(.25) = 75 301 - 75 = 226 rrx + nrx = trx 226 + 481 = 707 (other than actual new prescriptions) 707/782 (100) = 90% retention for this week 90% of these prescriptions, for whatever reason, were refilled. make it affordable and get it covered and we’ll be golden. ✌🏻😎 |
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Post by sportsrancho on Feb 27, 2020 13:16:03 GMT -5
From Steve....
Copy that nylefty
Use 90 instead of 350...
The fact is that the rate is toxic...
and investors shouldn't have to grind numbers to prove what MNKD knows.
Regarding Pguerrero
The other drugs are junk because they don't protect the pancreas.
Make the case and patients will listen.
Problem for PG/MNKD is that they can't say this stuff and we can and do every day.
Sub Q protects but doesn't engage the liver.
Afrezza does both protect and engage.
NOTHING LIKE IT ON THE PLANET...oops! ....well ... Endogenous Insulin.
T2s not being able to inhale 12/24/36 units of Afrezza? BS it's happening every day.
The dreaded cough... it's just not a big deal for us. Does it occur ? All the time.
It's how you prepare the patient.
Minimizing the dosing is key especially regarding compliance.
For now, the price is an issue but we still get those with amazing results covered and most get amazing results.
It's one thing to hear a rep(poss) saying that they can't sell Afrezza. It is a whole different problem to hear them lose faith in Afrezza. This person clearly blames the drug.
Most important take away from this is that Afrezza is Everything Al said it was/is.
Things are moving for VDEX and investors will be more than pleased.
SDB
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Post by boca1girl on Feb 27, 2020 13:16:26 GMT -5
I wouldn’t blame SA for any typos, MC is infamous for mumbling-fast-talk. That's a really lame jab. Did we run out of 410 today or just full of hate? No Mango, I agree with Brotherm. Mike does mumble a lot. I have a hard time understanding what he says sometimes. He is not the greatest public speaker, especially for a CEO. |
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Post by mango on Feb 27, 2020 13:21:34 GMT -5
I think he is a fantastic public speaker!
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