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Post by u1682002 on May 12, 2017 15:28:09 GMT -5
Sept 30 is the date and MNKD seems have enough cash to last to that date. Gut feeling is that MNKD will get the label change approved this time. I feel this can be the real turning point for MNKD, do you agree? I intend to buy more Jan 18 call options.
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Post by cedafuntennis on May 12, 2017 15:43:32 GMT -5
If they get it I agree. Not soon enough till the new head of the FDA starts to make approvals better and get rid of the quota fillers they have on staff like you saw at the approval meeting... Those morons were only hired to meet a quota as they had no brains.
With that said, Jan 18 may be way too soon. I would push the Jan 19 if I were you.
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Post by derek2 on May 12, 2017 15:57:54 GMT -5
Depends upon the change. Ray Urbanski gave some detail on the Q1 call:
1. Starting dose and dose adjustment concepts - probably no immediate effect. Not sure of the data that MNKD will use to convince the FDA. If it leads to patient retention and therefore Rx growth, then some later effect, but it would be probably attributed to the sales force.
2. Other label components consist of changes to the PK/PD comparative statements. Replacement of PK/PD graph from the one that currently is there. - I really don't know if this will be approved, but let's assume so. If they can get the onset of action wording changed (to, like "10 minutes vs. 30 minutes for SC) then that could be a differentiator to use in advertising. If they advertise.
3. Direct comparative data to other rapid-acting analogs. That could be seen as good news. They had better hope that they get a different FDA statistician since the last one heaped disdain on MNKD's methods of comparison. Again, if approved, then they could use it in advertising or by sales reps.
Not 4. Time in range is just being studied now (initiation of study), so that isn't part of this submission. It will have to wait for another submission and 10 month wait after trial completion and analysis.
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Post by lakers on May 12, 2017 17:11:23 GMT -5
We're going to look at the pediatric population. So, we are going to work with generating data that will demonstrate that Afrezza is safe and effective in this population. As you all know, this is a requirement to get regulatory approval to launch this drug in any jurisdiction. So, let me speak a little bit about the actual studies themselves. So, we are approaching our pediatric indication as a program. So, we are looking -- we have formed I should say a Pediatric Steering Committee that consists of top tier KOLs, academic centers and organization such as the JDRF.
We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies to address patient, provider and payer needs. We anticipate the first study in this program the PK-Start program I should say to start around June 15th. We are hoping to capitalize on the summer months to recruit these pediatric patients a little bit more quickly.
Once completed, these will open the floodgate for all kinds of biz dev.
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Post by peppy on May 12, 2017 17:15:25 GMT -5
Depends upon the change. Ray Urbanski gave some detail on the Q1 call: 1. Starting dose and dose adjustment concepts - probably no immediate effect. Not sure of the data that MNKD will use to convince the FDA. If it leads to patient retention and therefore Rx growth, then some later effect, but it would be probably attributed to the sales force. 2. Other label components consist of changes to the PK/PD comparative statements. Replacement of PK/PD graph from the one that currently is there. - I really don't know if this will be approved, but let's assume so. If they can get the onset of action wording changed (to, like "10 minutes vs. 30 minutes for SC) then that could be a differentiator to use in advertising. If they advertise. 3. Direct comparative data to other rapid-acting analogs. That could be seen as good news. They had better hope that they get a different FDA statistician since the last one heaped disdain on MNKD's methods of comparison. Again, if approved, then they could use it in advertising or by sales reps. Not 4. Time in range is just being studied now (initiation of study), so that isn't part of this submission. It will have to wait for another submission and 10 month wait after trial completion and analysis. That is not what I heard. I will listen again. |
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Post by peppy on May 12, 2017 17:19:44 GMT -5
We're going to look at the pediatric population. So, we are going to work with generating data that will demonstrate that Afrezza is safe and effective in this population. As you all know, this is a requirement to get regulatory approval to launch this drug in any jurisdiction. So, let me speak a little bit about the actual studies themselves. So, we are approaching our pediatric indication as a program. So, we are looking -- we have formed I should say a Pediatric Steering Committee that consists of top tier KOLs, academic centers and organization such as the JDRF. We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies to address patient, provider and payer needs. We anticipate the first study in this program the PK-Start program I should say to start around June 15th. We are hoping to capitalize on the summer months to recruit these pediatric patients a little bit more quickly. Once completed, these will open the floodgate for all kinds of biz dev. In my reading today, 200,000 cases of type 1 diabetes diagnosed per year USA. If half are under 18? insurance meet mother of devastation.
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Post by derek2 on May 12, 2017 17:21:56 GMT -5
We're going to look at the pediatric population. So, we are going to work with generating data that will demonstrate that Afrezza is safe and effective in this population. As you all know, this is a requirement to get regulatory approval to launch this drug in any jurisdiction. So, let me speak a little bit about the actual studies themselves. So, we are approaching our pediatric indication as a program. So, we are looking -- we have formed I should say a Pediatric Steering Committee that consists of top tier KOLs, academic centers and organization such as the JDRF. We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies to address patient, provider and payer needs. We anticipate the first study in this program the PK-Start program I should say to start around June 15th. We are hoping to capitalize on the summer months to recruit these pediatric patients a little bit more quickly. Once completed, these will open the floodgate for all kinds of biz dev. The question was regarding the changes to the label for the submission with the Sept 30 PDUFA date. Pediatric isn't finished yet (trials aren't even approved yet), so that's not part of the submission. |
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Post by lakers on May 12, 2017 17:21:57 GMT -5
Sept 30 is the date and MNKD seems have enough cash to last to that date. Gut feeling is that MNKD will get the label change approved this time. I feel this can be the real turning point for MNKD, do you agree? I intend to buy more Jan 18 call options. Depending on how fast UAE develops. This could address the $10M Note due in July, and $30M to extend the runway to Jan 2018. I also expect Canada to quickly follow. "I can announce today that we are actually on file in one new listed country and are in later stage negotiations in number of different jurisdictions, and you'll see announcement of that one near-term. But as this typical with our past practices, we cannot to make these announcements till we actually get the approvals or sign the agreement, so stay tuned on that front as well." seekingalpha.com/article/4072017-mannkinds-mnkd-ceo-matthew-pfeffer-q1-2017-results-earnings-call-transcript?part=single"filings for Brazil, Canada, Mexico, Australia, MENA, and the UAE. We are also evaluating EMA and other regions" Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=19#ixzz4guDJ2kRs |
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Post by lakers on May 12, 2017 17:25:52 GMT -5
We're going to look at the pediatric population. So, we are going to work with generating data that will demonstrate that Afrezza is safe and effective in this population. As you all know, this is a requirement to get regulatory approval to launch this drug in any jurisdiction. So, let me speak a little bit about the actual studies themselves. So, we are approaching our pediatric indication as a program. So, we are looking -- we have formed I should say a Pediatric Steering Committee that consists of top tier KOLs, academic centers and organization such as the JDRF. We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies to address patient, provider and payer needs. We anticipate the first study in this program the PK-Start program I should say to start around June 15th. We are hoping to capitalize on the summer months to recruit these pediatric patients a little bit more quickly. Once completed, these will open the floodgate for all kinds of biz dev. The question was regarding the changes to the label for the submission with the Sept 30 PDUFA date. Pediatric isn't finished yet (trials aren't even approved yet), so that's not part of the submission. The Ped PK-Start is short, should finish this year if started on time in June 2017. |
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Post by derek2 on May 12, 2017 17:26:08 GMT -5
Depends upon the change. Ray Urbanski gave some detail on the Q1 call: 1. Starting dose and dose adjustment concepts - probably no immediate effect. Not sure of the data that MNKD will use to convince the FDA. If it leads to patient retention and therefore Rx growth, then some later effect, but it would be probably attributed to the sales force. 2. Other label components consist of changes to the PK/PD comparative statements. Replacement of PK/PD graph from the one that currently is there. - I really don't know if this will be approved, but let's assume so. If they can get the onset of action wording changed (to, like "10 minutes vs. 30 minutes for SC) then that could be a differentiator to use in advertising. If they advertise. 3. Direct comparative data to other rapid-acting analogs. That could be seen as good news. They had better hope that they get a different FDA statistician since the last one heaped disdain on MNKD's methods of comparison. Again, if approved, then they could use it in advertising or by sales reps. Not 4. Time in range is just being studied now (initiation of study), so that isn't part of this submission. It will have to wait for another submission and 10 month wait after trial completion and analysis. That is not what I heard. I will listen again. Here you go: seekingalpha.com/article/4072017-mannkinds-mnkd-ceo-matthew-pfeffer-q1-2017-results-earnings-call-transcript?part=singleYou can text search for: Starting dose and dose adjustment concepts Other label components consist of changes to the PK/PD comparative statements. Replacement of PK/PD graph from the one that currently is there. Direct comparative data to other rapid-acting analogs. In order to find the relevant sections. |
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Post by peppy on May 12, 2017 17:37:25 GMT -5
This is what I heard. So, let me talk a little bit about Afrezza label of submission. So, first it provides clarity on starting dose and dose adjustment concepts. This is vitally important to ensure that patients use Afrezza appropriately. This will help us retain patients once they start using Afrezza. Other label components consist of changes to the PK/PD comparative statements. We have replacement of PK/PD graph from the one that currently is there. I’ll talk about this is a moment.
We also requested, updated line goods that reflects the most recent data more actively. Some of this includes for example, direct comparative data to other rapid-acting analogs. We expect the date label approval, the PDUFA date to be September 30, 2017. Now, as it's typical for the FDA, we don’t expect to hear back from them regarding any label components and so probably up to July or August timeframe.
Reading it super quickly, after this paragraph, he mentioned time in range, pediatric, we know they will not be done. Label change one and two? a two step?
This isn't another case where we have to act like we can not see is it? www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
Cmax and AUC were dose proportional for TI but slightly sublinear for
Lispro; saturable GIRmax was obtained over the dose range for both
insulins. Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. Dose-response was almost linear up to 48U TI and 30 U Lispro.
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Post by mnholdem on May 12, 2017 17:45:23 GMT -5
I think the odds are good. CMO Dr. Raymond Urbanski has been around the block a few times with the FDA before CEO Pfeffer lured him to MannKind. Kudos to you, Matt.
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Post by cjm18 on May 12, 2017 17:51:27 GMT -5
What are the odds we get peds approval before January?
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Post by u1682002 on May 12, 2017 17:58:43 GMT -5
Depends upon the change. Ray Urbanski gave some detail on the Q1 call: 1. Starting dose and dose adjustment concepts - probably no immediate effect. Not sure of the data that MNKD will use to convince the FDA. If it leads to patient retention and therefore Rx growth, then some later effect, but it would be probably attributed to the sales force. 2. Other label components consist of changes to the PK/PD comparative statements. Replacement of PK/PD graph from the one that currently is there. - I really don't know if this will be approved, but let's assume so. If they can get the onset of action wording changed (to, like "10 minutes vs. 30 minutes for SC) then that could be a differentiator to use in advertising. If they advertise. 3. Direct comparative data to other rapid-acting analogs. That could be seen as good news. They had better hope that they get a different FDA statistician since the last one heaped disdain on MNKD's methods of comparison. Again, if approved, then they could use it in advertising or by sales reps. Not 4. Time in range is just being studied now (initiation of study), so that isn't part of this submission. It will have to wait for another submission and 10 month wait after trial completion and analysis. Hi Derek2, thank you for your direct answer to my questions. I would like to ask again to everyone on this board, do you think the stock price will rise significantly (>30%) if MNKD get approval of label change as it wishes? I agree with MN that the odds is good this time. This is why I am thinking to bet on this decision. |
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Post by sophie on May 12, 2017 18:17:03 GMT -5
Not derek, but thought I could possibly be helpful anyway. Hoping at least.
The way I see it, you don't have to bet. Look at the market cap right now. Then think about how much a label change would have to increase the market cap to increase your shares to a satisfactory price. Measure that window. Do you really need to catch the very bottom, or would you be willing to shave off a few tenths for peace of mind?
If the label change makes a significant difference, the share price will easily triple from where it is now. It won't take much for this company to take off. About a year ago this company was worth $10/share adjusted for split.
In my opinion, there will be plenty of opportunity to get in and make good money. You might miss out on the initial surge, but if you're not into taking risks, don't. You'll still make out just fine...
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