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Post by sportsrancho on Mar 12, 2017 9:52:16 GMT -5
Tom's scripts for his kids are good for a year. Do people get 3 month scripts? He buys Afrezza every 3 months. His daughter just renewed her script and Health Net just up and denied it. He's never had any trouble with them before and pays around $60 per month for each child. Being a very long MNKD long... he taught them how to dose. No problems there:-) He's being trying for weeks now to get the 8 and 12 packs and CVS says they can't get them. They said they had 8 boxes but they were on hold for other people. WTH? Quote: His daughter just renewed her script and Health Net just up and denied it.
Reply: How often is this happening? Is this part of the refill problem?
Sports, why doesn't tom try and get the titration pack? New prescription difficult to obtain?
I believe the titration pack is what he is trying to get for his son and CVS won't fill it. I don't know yet if he was able to get it at Walmart. They are suppose to be able to order it and have it with in days. His son is 18 now so won't be going to their Ped Endo anymore. So he has to get a script from VDex or Rancho Medical. So that won't be a problem. His daughter ( 16 ) just renewed her one year script from the Ped Endo and got denied by their insurance. I see it as insurance being the problem. And people not taking enough Afrezza at first before they learn how.
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Post by peppy on Mar 12, 2017 21:25:47 GMT -5
Quote: His daughter just renewed her script and Health Net just up and denied it.
Reply: How often is this happening? Is this part of the refill problem?
Sports, why doesn't tom try and get the titration pack? New prescription difficult to obtain?
I believe the titration pack is what he is trying to get for his son and CVS won't fill it. I don't know yet if he was able to get it at Walmart. They are suppose to be able to order it and have it with in days. His son is 18 now so won't be going to their Ped Endo anymore. So he has to get a script from VDex or Rancho Medical. So that won't be a problem. His daughter ( 16 ) just renewed her one year script from the Ped Endo and got denied by their insurance. I see it as insurance being the problem. And people not taking enough Afrezza at first before they learn how. Quote: I believe the titration pack is what he is trying to get for his son and CVS won't fill it. Reply: Have we found part of our refill problem? The pharmacies are not filling?
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Post by sportsrancho on Mar 12, 2017 22:14:53 GMT -5
I believe the titration pack is what he is trying to get for his son and CVS won't fill it. I don't know yet if he was able to get it at Walmart. They are suppose to be able to order it and have it with in days. His son is 18 now so won't be going to their Ped Endo anymore. So he has to get a script from VDex or Rancho Medical. So that won't be a problem. His daughter ( 16 ) just renewed her one year script from the Ped Endo and got denied by their insurance. I see it as insurance being the problem. And people not taking enough Afrezza at first before they learn how. Quote: I believe the titration pack is what he is trying to get for his son and CVS won't fill it. Reply: Have we found part of our refill problem? The pharmacies are not filling?
Tom is a very persistent guy! He tired for weeks before he talked to someone at MNKD. Although he never had a problem before. So not sure, it seems like from Twitter that it is a problem. I can tell you it puts the fear of God into a parent! And that's because Afrezza is that good! There is no going back to what life was like without it once you've been on it and have it figured out.
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Post by Deleted on Mar 12, 2017 22:16:53 GMT -5
Quote: I believe the titration pack is what he is trying to get for his son and CVS won't fill it. Reply: Have we found part of our refill problem? The pharmacies are not filling?
Tom is a very persistent guy! He tired for weeks before he talked to someone at MNKD. Although he never had a problem before. So not sure, it seems like from Twitter that it is a problem. I can tell you it puts the fear of God into a parent! And that's because Afrezza is that good! There is no going back to what life was like without it once you've been on it and have it figured out. he must have tried and got tired . What did that some one at MNKD say? stay tuned?
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Post by peppy on Mar 17, 2017 8:09:48 GMT -5
From the March 16 4q conference call.
We are preparing to relaunch the Afrezza pediatric program. We are approaching this activity much like we would a new product launch to garner excitement and enthusiasm for the use of Afrezza in the pediatric population. As part of these activities, we are leveraging our relationship with the JDRF, an organization dedicated to the treatment of pediatric diabetes.
In addition, since the spending enrollment in the pediatric PK study at the time of the Sanofi transition, we have amended the protocol and resubmitted it to the FDA. We expect to reopen enrollment this coming quarter in parallel to our pediatric program re-launch efforts that I have mentioned briefly above.
Finally, we are mapping out a strategy that will significantly reduce the time to filing for a pediatric indication. This will obviously involve some discussions with the FDA and we’ll update people as we get – as we progress.
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Post by Deleted on Mar 17, 2017 8:28:16 GMT -5
From the March 16 4q conference call.
We are preparing to relaunch the Afrezza pediatric program. We are approaching this activity much like we would a new product launch to garner excitement and enthusiasm for the use of Afrezza in the pediatric population. As part of these activities, we are leveraging our relationship with the JDRF, an organization dedicated to the treatment of pediatric diabetes.
In addition, since the spending enrollment in the pediatric PK study at the time of the Sanofi transition, we have amended the protocol and resubmitted it to the FDA. We expect to reopen enrollment this coming quarter in parallel to our pediatric program re-launch efforts that I have mentioned briefly above.
Finally, we are mapping out a strategy that will significantly reduce the time to filing for a pediatric indication. This will obviously involve some discussions with the FDA and we’ll update people as we get – as we progress.
This is paramount!
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Post by sportsrancho on Mar 17, 2017 9:07:56 GMT -5
Happy Dance! #Afrezzakids
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Post by peppy on Mar 17, 2017 11:40:53 GMT -5
From the March 16 4q conference call.
We are preparing to relaunch the Afrezza pediatric program. We are approaching this activity much like we would a new product launch to garner excitement and enthusiasm for the use of Afrezza in the pediatric population. As part of these activities, we are leveraging our relationship with the JDRF, an organization dedicated to the treatment of pediatric diabetes.
In addition, since the spending enrollment in the pediatric PK study at the time of the Sanofi transition, we have amended the protocol and resubmitted it to the FDA. We expect to reopen enrollment this coming quarter in parallel to our pediatric program re-launch efforts that I have mentioned briefly above.
Finally, we are mapping out a strategy that will significantly reduce the time to filing for a pediatric indication. This will obviously involve some discussions with the FDA and we’ll update people as we get – as we progress.
Does that mean this quarter or the third quarter? I see it is open to interpretation. I thought it meant this quarter. Q 1. I suppose we could email mnkd and ask, 1st quarter or second quarter. yesterdays report was the 4th quarter report? I can be wrong as we all have seen ad nauseam.
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Post by goyocafe on Mar 31, 2017 11:50:45 GMT -5
Please announce the start of this trial on Monday. Please!
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Post by careful2invest on Mar 31, 2017 12:42:03 GMT -5
Please announce the start of this trial on Monday. Please! That would certainly be nice!! We need a spark!! And Sports wrote... "I see it as insurance being the problem. And people not taking enough Afrezza at first before they learn how." I agree on both counts, but I am blown away that MNKD had not already learned and established the best methods of titration before launch. For a patient not to know how much to take of any drug is dangerous and extremely irresponsible of the company that launched the drug! It just does not make sense!
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Post by radgray68 on Mar 31, 2017 14:58:53 GMT -5
Al commented long ago on the lack of proper titration seen in the FDA studies. He said something about Doctors not being aggressive enough. That was in the context of reviewing the trial data back in 2013,2014(?) or so. The problem with lower efficacy seems to have been realized and they did add the 12 unit dose, which was good, but......is it enough? It may be time for 16 and 24 unit doses, especially for T-2's, leaving the 4, 8 and 12's for the pediatric patients? Just spit balling here because I think all this "corrective dosing" afterward is tainting the experience for first time users. Convenience was the selling point on Afrezza back in the day.
I do remember this statement: "You have to be trying to get a hypo"
I just hope the educators are addressing this.
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Post by careful2invest on Mar 31, 2017 15:58:02 GMT -5
Al commented long ago on the lack of proper titration seen in the FDA studies. He said something about Doctors not being aggressive enough. That was in the context of reviewing the trial data back in 2013,2014(?) or so. The problem with lower efficacy seems to have been realized and they did add the 12 unit dose, which was good, but......is it enough? It may be time for 16 and 24 unit doses, especially for T-2's, leaving the 4, 8 and 12's for the pediatric patients? Just spit balling here because I think all this "corrective dosing" afterward is tainting the experience for first time users. Convenience was the selling point on Afrezza back in the day.
I do remember this statement: "You have to be trying to get a hypo"
I just hope the educators are addressing this. Great point! "You have to be trying to get a hypo" That said, a stronger initial dose makes sense to me as well! But I am not a scientist specializing in this field. And rad, I have no idea of your background, But,
Shouldn't MNKD have already completed several studies pertaining to this very issue long before now? Here again, MNKD has to be reactive instead of proactive. To be successful, one must stay ahead of the curve and never behind the eight ball! MNKD always seems to find themselves behind the eight ball...and here we are Again! It just does not make sense! I am trying to remain positive for many reasons. Actually a few hundred thousand reasons! Here are a few things that help me to not lose all hope. 1) AFREZZA works, and works well! (That is a fundamental fact) 2) Pediatric study with JDRF for the use of AFREZZA. (This in itself can be huge) 3) Insurance coverage is improving. (Imperative) 4) New label (Should help the cause) 5) The chart that has been posted about how many years it generally takes for a new drug to be successful along with the gradual climb that is involved, totalling 3 to 5 years. (Requires Patience) We lost about a year and a half in the debacle with Sanofi, (plus so much more) so we are basically in our first year of an honest effort to launch AFREZZA. 6) Other positive promotional things are in the works for the near future, (but imho, they should have been happening long ago) Lets hope that the ADA Conference in Chicago goes well this weekend and opens more eyes to the benefits of AFREZZA One day at a time!
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Post by radgray68 on Mar 31, 2017 17:07:01 GMT -5
Agree completely. Unfortunately, I'm not an endo or a diabetic. I just take x-rays of foot ulcers on diabetic patients and feel there HAS to be a better way. Afrezza seems so close to that better way, but I hear so much about a second dose after meals. Why not just take a little larger dose at the beginning of the meal? I seem to recall something about waiting until 5 minutes in as a possible solution. Al didn't seem have a problem with that.
Thanks to this recent bear raid, I have an additional 25 calls for 2019 as a last ditch effort to not miss out on the possibility of success. One way or another, we'll know what's up by then. GLTY
One encouraging thing, I finally had a patient come in who knew about Afrezza and was talking to his endo about it. I'm always very careful not to say too much for legal reasons, of course, but I took it as a positive. Maybe I'll get my money back after all.
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Post by sportsrancho on Mar 31, 2017 17:21:49 GMT -5
Agree completely. Unfortunately, I'm not an endo or a diabetic. I just take x-rays of foot ulcers on diabetic patients and feel there HAS to be a better way. Afrezza seems so close to that better way, but I hear so much about a second dose after meals. Why not just take a little larger dose at the beginning of the meal? I seem to recall something about waiting until 5 minutes in as a possible solution. Al didn't seem have a problem with that.
Thanks to this recent bear raid, I have an additional 25 calls for 2019 as a last ditch effort to not miss out on the possibility of success. One way or another, we'll know what's up by then. GLTY
One encouraging thing, I finally had a patient come in who knew about Afrezza and was talking to his endo about it. I'm always very careful not to say too much for legal reasons, of course, but I took it as a positive. Maybe I'll get my money back after all. The teenagers take a 8 or 12 unit 10 min in. No follow up dose. I'm so jealous over those calls:-) Which strike did you buy if you don't mind me asking?
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Post by radgray68 on Mar 31, 2017 17:46:28 GMT -5
I'm the entire open interest on the $2.50 leaps. Of course, as is always the case with options, they went down a little further today. I'm figuring we only have to get back to a $250 Mil market cap to break even on the strike. However, if that happens this year, say after several months of increased sales combined with good news on the pediatric trials, then the calls will start showing time value that could double or triple the price. I saw it happen when the trial results were first reported way back when. The stock moved from $2 to almost $4 but my $5 calls had $3 in time value all of a sudden. I also converted my pre-split $1 calls to $5 ones. It's a long shot from here but that's what mad money is for.
To keep with the theme of the thread, though, I see the pedriatric population as our saving grace. From your post : "The teenagers take a 8 or 12 unit 10 min in. No follow up dose." Leave it up to youngsters to find a better way. LOL
Read more: mnkd.proboards.com/thread/7419/pediatric-study?page=2#ixzz4cwqdyN42
As usual, "historical performance is not indicative of future blah blah blah......"
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