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Post by james on Apr 20, 2015 18:03:37 GMT -5
YMB is speculating that this is the 'new process' we have heard mentioned (without elaboration of what that means) and that lines 2 and 3 will use this. That leads to the further speculation that 2 and 3 are ready to roll.
The only comment I would make on this is that I had in mind that certification for lines 2 and 3 was still a month or more out. I don't recall where that timeline came from.
I did like liane's suggestion that there may be a different packaging for hospital use. That made some sense to me.
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Post by otherottawaguy on Apr 20, 2015 18:52:22 GMT -5
The other one that catches my eye is this one:
NDC 47918-048-33, AFREZZA (insulin human [rDNA origin]) Inhalation Powder: 180 cartridges; 90 - 4 unit cartridges and 90 – 8 unit cartridges and 2 inhalers
Have we heard anything about a double barrel pack? if a 90 is $280(ish) could a 180 be $475(ish) or about the average prescription value?
I have been looking at the 475 as two boxes, at an insurance pricing adjusted value.
OOG
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Post by otherottawaguy on Apr 20, 2015 19:00:49 GMT -5
YMB is speculating that this is the 'new process' we have heard mentioned (without elaboration of what that means) and that lines 2 and 3 will use this. That leads to the further speculation that 2 and 3 are ready to roll... I had contacted Matt back in January and this was his response (including the misspelling of his name - oops):
"The two additional lines are in place but must go through a lengthy testing and validation process. Will likely take another couple of months. A good reason to build up healthy pre-launch inventory.
Matt
Sent from my iPhone
On Jan 23, 2015, at 12:56 PM, Other Ottawa Guy <OOG@OOG.com<mailto:OOG wrote:
Mr Pheffer:
Is there anyway that you can clear up how many production lines are currently certified and producing product at Danbury?
We know there is at least one (would have been hard to meet the production quota for launch), just wondering about the other two that you have mentioned that are about 10% greater in capacity that were supposed to have been on line in 2015. Speculation is that they are not online yet followed by speculation that they are avail and that is how the quota was met early.
Nice to have heard back from you before Christmas in response to my phone call.
Sincerely, OOG"
So if this was back on Jan 23 and it actually took 2 months (lets say 3 just to give him some wiggle room), these lines should be on line as of last month (or this week). Worst case scenario do we get introduced to them at the Shareholder meeting
OOG
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Post by EveningOfTheDay on Apr 21, 2015 1:27:57 GMT -5
I had contacted Matt back in January and this was his response (including the misspelling of his name - oops):
"The two additional lines are in place but must go through a lengthy testing and validation process. Will likely take another couple of months. A good reason to build up healthy pre-launch inventory.
Matt
Sent from my iPhone
On Jan 23, 2015, at 12:56 PM, Other Ottawa Guy <OOG@OOG.com<mailto:OOG wrote:
Mr Pheffer:
Is there anyway that you can clear up how many production lines are currently certified and producing product at Danbury?
We know there is at least one (would have been hard to meet the production quota for launch), just wondering about the other two that you have mentioned that are about 10% greater in capacity that were supposed to have been on line in 2015. Speculation is that they are not online yet followed by speculation that they are avail and that is how the quota was met early.
Nice to have heard back from you before Christmas in response to my phone call.
Sincerely, OOG"
So if this was back on Jan 23 and it actually took 2 months (lets say 3 just to give him some wiggle room), these lines should be on line as of last month (or this week). Worst case scenario do we get introduced to them at the Shareholder meeting
OOG
OOG, I contacted Matt just a few days ago to ask him precisely about lines 2 and 3. His answer was that even though he could not share a precise date, the lines were expected to be FDA certified and producing sometime this quarter. A part of me thinks it would make total sense that they reveal this at the shareholders meeting. Perhaps is wishful thinking, but it definitely might be a good way to disarm quite a few belligerent shareholders, given what the share price action has been in the last couple of weeks.
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Post by ezrasfund on Apr 21, 2015 8:59:21 GMT -5
By the end of the quarter is exactly the guidance that Hakan gave at the last conference call, and that would be before June 30th. Remember that although Matt may respond to our questions he cannot reveal any previously undisclosed material information. What this does say is that schedules are still on track with regard to the two additional lines.
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Post by sullykraft on Apr 21, 2015 10:54:17 GMT -5
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Post by joeypotsandpans on Apr 21, 2015 11:17:40 GMT -5
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Post by otherottawaguy on Apr 21, 2015 11:25:02 GMT -5
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Post by stevedc34 on Apr 21, 2015 11:25:26 GMT -5
Joey. Any idea what, "change in ownership of the NDA to Sanofi-aventis" means?
RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS The REMS for Afrezza was originally approved on June 27, 2014. The REMS consists of a communication plan, and a timetable for submission of assessments of the REMS. Your proposed modifications to the REMS consist of changes to the REMS and REMS materials to reflect a change in ownership of the NDA to Sanofi-aventis. In addition, a correction was made in the wording of a sentence in the REMS regarding placement of a link in the Afrezza product website to the REMS website.
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Post by dstevenson on Apr 21, 2015 11:35:49 GMT -5
Yea I saw that too, can someone put it in everyday joe words for me on this nsa that was approved yesterday and the ownership Sanofi thing. I don't understand
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Post by Chris-C on Apr 21, 2015 12:12:39 GMT -5
Yea I saw that too, can someone put it in everyday joe words for me on this nsa that was approved yesterday and the ownership Sanofi thing. I don't understand Excellent question- this motivates me to go back and read more about the agreement between Mannkind and Sanofi. Given that the FDA is communicating with Sanofi on issues related to REMS, and noting that the recent patent documents also named Sanofi, questions about the legal nature of the agreement and the implications of this going forward come to mind. My understanding was that MNKD licensed the technology to Sanofi with an explicit agreement about marketing, sales, revenue and expense sharing, market expansion, regulatory issues, and conditions related to continuing their relationship going forward. As I recall, there were redacted portions of some parts of the agreement; but hopefully, some of the uncertainties about the arrangement will be answered in the upcoming conference. I'm beginning to think there is every likelihood that the controlled launch is based on the projected certification of the new lines and possibly the approval of a new 12u cartridge. I'd love to know what the FDA requires for approval of a new cartridge. Presumably, since they clearly have approved 4 and 8 unit doses, the combination of the two within a single cartridge is simply a packaging and labeling issue. Somehow, I get the feeling that things are beginning to pick up speed on several fronts. GLTA Chris
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Post by mnholdem on Apr 21, 2015 12:35:10 GMT -5
Agreed. It's also my understanding that the production method for the cartridge must first be approved before the cartridge itself gets final approval. FDA doesn't issue "contingent upon" approvals to my knowledge (chuckle).
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Post by derek2 on Apr 21, 2015 12:42:55 GMT -5
Yea I saw that too, can someone put it in everyday joe words for me on this nsa that was approved yesterday and the ownership Sanofi thing. I don't understand It states that SNY is legally accountable for maintaining the good standing of the NDA, complying with terms of the approval (REMS, follow-on studies, labelling requirements, etc.) and is the entity responsible for dealing with the FDA on matters related to Afrezza. It makes sense, since SNY is responsible for submitting the SNDAs, taking on compliance responsibilities, and conducting post-marketing studies. This allows them to deal with the FDA directly as the owner of the (approved) NDA for Afrezza.
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Post by joeypotsandpans on Apr 21, 2015 12:55:40 GMT -5
Joey. Any idea what, "change in ownership of the NDA to Sanofi-aventis" means? RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS The REMS for Afrezza was originally approved on June 27, 2014. The REMS consists of a communication plan, and a timetable for submission of assessments of the REMS. Your proposed modifications to the REMS consist of changes to the REMS and REMS materials to reflect a change in ownership of the NDA to Sanofi-aventis. In addition, a correction was made in the wording of a sentence in the REMS regarding placement of a link in the Afrezza product website to the REMS website. This is purely a guess on my part but given the language of the partnership when announced: "Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary" I would venture to say that since SNY is the one going forward that will be submitting to the FDA for various amendments/additions to labeling and usage, etc. that their name is the one that is referred to on the NDA...these are technicalities that I am definitely not versed in. At this point, I'm not reading too much into it regarding any real change of ownership, rather more of a semantics nature, again jmo
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Post by kpm1028 on Apr 27, 2015 17:55:53 GMT -5
Can we confirm if the 12u was 002 or 003 from the supplemental filings?
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