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Post by Deleted on Apr 21, 2015 13:12:20 GMT -5
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Post by mnholdem on Apr 21, 2015 13:18:38 GMT -5
Gold... I like that color choice for the 12-unit cartridge very much. Very fitting, don't you think? After all, this cartridge will have the highest profit margin of any of the cartridges and will enable MannKind to achieve a higher production capacity (units/line) to meet demand.
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Post by jpg on Apr 21, 2015 13:22:06 GMT -5
All they are missing is a 2 unit dose and we have a full therapeutic range.
It wouldn't surprise me if the safe price action we have recently seen was not primitively done to mitigate any positive news (like 12 units becoming available).
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Post by Deleted on Apr 21, 2015 13:22:14 GMT -5
Gold... I like that color choice for the 12-unit cartridge very much. Very fitting, don't you think? After all, this cartridge will have the highest margin and will enable higher capacity (units/line) to supply demand.
yes.. The production just doubled considering a 8 unit + 4 unit combo and tripled considering just 4 units... |
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Post by traderdennis on Apr 21, 2015 13:37:22 GMT -5
I would imagine large insurance companies are likely to negotiate a monthly rate as opposed to a per unit rate for this product. But this is super news in that T2's need much larger doses as they have an insulin resistance issue as opposed to t1's. This gets up to no more than 2 cartridges per meal up to 24 units.
I would imagine the next size up will probably be 18 or 24/25 is probably the next size up. I have heard up to 50-100 units per meal for very insulin resistant T2's.
On a very plus note. if 90% of your market is T2 vrs T1, then we get so much closer to a hard launch with advertising. Why bring in t2's if they are going to need to inhale 2-3 cartridges per dose.
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Post by otherottawaguy on Apr 21, 2015 13:39:56 GMT -5
Thar she blows (or should I say inhales)...
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Post by otherottawaguy on Apr 21, 2015 13:45:19 GMT -5
From the PDF:
------------------DOSAGE FORMS AND STRENGTHS ---------------
AFREZZA is available as single-use cartridges of: (3)
•4 units
•8 units
•12 units
The dosage pdf must be a new addition in the last few hours because the site only showed the letter this morning.
Great news!
OOG
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Post by tripoley on Apr 21, 2015 13:47:42 GMT -5
I would imagine large insurance companies are likely to negotiate a monthly rate as opposed to a per unit rate for this product. But this is super news in that T2's need much larger doses as they have an insulin resistance issue as opposed to t1's. This gets up to no more than 2 cartridges per meal up to 24 units. I would imagine the next size up will probably be 18 or 24/25 is probably the next size up. I have heard up to 50-100 units per meal for very insulin resistant T2's. On a very plus note. if 90% of your market is T2 vrs T1, then we get so much closer to a hard launch with advertising. Why bring in t2's if they are going to need to inhale 2-3 cartridges per dose. We've also got the T2s on Lantus that are uncontrolled and don't want to start shots. |
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Post by alethea on Apr 21, 2015 13:56:18 GMT -5
This is really good news for the Type 2 market. Hopefully manufacturing Lines 2 and 3 are soon approved and much improved sales follow fairly quickly. I certainly hope so. |
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Post by tchalaa on Apr 21, 2015 14:12:38 GMT -5
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis
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Post by Deleted on Apr 21, 2015 14:15:29 GMT -5
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Post by BlueCat on Apr 21, 2015 14:44:18 GMT -5
Hey - Does anyone have insight (via previous cc's - I can't honestly remember) about how the production lines are setup to handle different cartridge sizes?
I'm assuming each line is able to handle more than one cartridge size, as currently, line 1 is producing both 4+8 sizes. Not sure if line 1 though, could also handle 12 - and if that would require re-approval from FDA.
Where I am going with this - if 12 is now listed on label, and only lines 2/3 would be capable of handling - that may suggest lines 2/3 approval is imminent (as originally projected by company for Q2 approval). Basically - we get 2 approvals announced at one time (perhaps ER cc).
I wonder too, just out of curiosity - if each line is capable of doing more than 1 cartridge size - might it be prudent for them to dedicate each of the three lines to 1 size at a time. I imagine there's some change-over time cost switching between sizes (even if just turning a dial). With three lines, they could have non-stop production now on each size - tho having the ability to switch would be beneficial in the future for fault-tolerance (e.g. if one line went down and another line had to do dual-duty ...)
Thoughts anyone?
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Post by tripoley on Apr 21, 2015 14:56:26 GMT -5
This is really good news for the Type 2 market. Hopefully manufacturing Lines 2 and 3 are soon approved and much improved sales follow fairly quickly. I certainly hope so. It is and there are 1.1M T2s on basal that need insulin intensification: Attachment Deleted |
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Post by benh on Apr 21, 2015 14:56:52 GMT -5
My thoughts are the lines can handle multiple types. But inefficiencies grow as you switch between. Therefore, I imagine one line will be fully dedicated to 12u carts. Based on production math, the announcement of this line being up and running is going to be announced sooner rather than later.
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Post by mnholdem on Apr 21, 2015 14:58:47 GMT -5
I am pretty certain that the manufacturing method (lines) had to be approved before the cartridge got the nod. I think 2 & 3 are running.
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