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Post by liane on Mar 2, 2015 18:20:30 GMT -5
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Post by mechstan on Mar 2, 2015 19:05:58 GMT -5
From the 10K:
"Before the Connecticut facility reaches its maximum capacity, we and Sanofi expect to coordinate the construction and qualification of an additional manufacturing facility, which may be owned and operated by Sanofi"
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Post by gwb on Mar 2, 2015 19:11:40 GMT -5
From the 10K: "Before the Connecticut facility reaches its maximum capacity, we and Sanofi expect to coordinate the construction and qualification of an additional manufacturing facility, which may be owned and operated by Sanofi" I am thrilled ! SNY will be taking the responsibility for manufacturing , I bet that will mean facilities not facility .
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Post by gwb on Mar 2, 2015 19:25:20 GMT -5
Here is the New Process Al mentioned ! Half way down page three .
Currently, we purchase the raw material from which we produce Technosphere particles (fumaryl diketopiperazine (“FDKP”)) from a major chemical manufacturer with facilities in Europe and North America. We also have the capability of manufacturing this chemical ourselves in our Danbury facility, where we recently completed pilot-scale development batches of FDKP produced using a more streamlined and less costly process compared to earlier campaigns. We intend to transfer this more efficient process to a contract manufacturer for production of registration and validation batches of FDKP.
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Post by mnholdem on Mar 2, 2015 20:50:41 GMT -5
This is the document that fills in a lot of the blanks. I'm currently reading the section that lists the diabetes drugs that Afrezza will be competing against. MannKind makes it crystal clear how much faster Afrezza is compared to competitors' drugs.
I'm beginning to think that this 10-K could be a catalyst resulting in investment advisor upgrades.
No joke. A number of questions are being answered in this document. Questions that investment advisors have been asking. Questions that investors have been asking. I have a feeling that I'm going to enjoy reading it.
I might even have to change my avatar back to The Thinker.
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Post by liane on Mar 2, 2015 20:57:45 GMT -5
So of course GS downgraded - putzes!
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Post by bobw on Mar 2, 2015 21:06:30 GMT -5
This is the document that fills in a lot of the blanks. I'm currently reading the section that lists the diabetes drugs that Afrezza will be competing against. MannKind makes it crystal clear how much faster Afrezza is compared to competitors' drugs. I'm beginning to think that this 10-K could be a catalyst resulting in investment advisor upgrades. No joke. A number of questions are being answered in this document. Questions that investment advisors have been asking. Questions that investors have been asking. I have a feeling that I'm going to enjoy reading it. I might even have to change my avatar back to The Thinker. "Several insulin products in development are reported to have a time-action profile that is more rapid than that of the currently available rapid-acting insulin analogs. Halozyme Therapeutics, Inc. has conducted Phase 2 clinical studies to evaluate the safety and efficacy of a formulation of human insulin or an insulin analog that is co-administered with human hyaluronidase enzyme. This enzyme temporarily degrades a naturally occurring, space-filling substance that is a major component of normal tissues throughout the body, thereby facilitating the penetration and diffusion of insulin that is injected under the skin." Although promising, I wouldn't worry about Halozyme's product for now. They put the project on hold so that they can concentrate on cancer therapies that appear more lucrative at this time.
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Post by beardawg on Mar 2, 2015 21:09:13 GMT -5
From the 10K: "Before the Connecticut facility reaches its maximum capacity, we and Sanofi expect to coordinate the construction and qualification of an additional manufacturing facility, which may be owned and operated by Sanofi" If I recall correctly, originally it had in the agreement filing that Sanofi could not make Afrezza (??build the building, either??) until all the MannKind facility was fully utilized. If I am correct, it speaks to another change indicating that uptake is faster than Sanofi expected.
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Post by mnholdem on Mar 2, 2015 21:40:25 GMT -5
Not fully built out. As I recall, after a certain capacity, say 60%, Sanofi must split expansion so that Danbury gets some of it, but this provision kicks in well before all 12 lines at Danbury are operation.
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Post by mnholdem on Mar 2, 2015 21:47:21 GMT -5
So of course GS downgraded - putzes! Unbelievable. I guess it's like Austin wrote the other day. This is a "battlefield stock" where both sides are absolutely convinced they are right. I think Goldman Sachs will soon discover that Sanofi is much better at marketing diabetes drugs than Pfizer ever was. Still...how long will it be before Sanofi fires those thrusters? March? April? "I picked a bad day to quit sniffing glue." - Lloyd Bridges, Airplane
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Post by bradleysbest on Mar 2, 2015 22:34:02 GMT -5
How come MNKD did not announce these developments last week as opposed to us finding out via the form 10 K? Seems they could have been out front on these developments.
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Post by kc on Mar 3, 2015 0:33:31 GMT -5
Putting the time closer that Sanofi BUYS INTO MannKind. It will happen. From the 10K: "Before the Connecticut facility reaches its maximum capacity, we and Sanofi expect to coordinate the construction and qualification of an additional manufacturing facility, which may be owned and operated by Sanofi" I am thrilled ! SNY will be taking the responsibility for manufacturing , I bet that will mean facilities not facility .
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Post by dreamboatcruise on Mar 3, 2015 14:26:01 GMT -5
Not fully built out. As I recall, after a certain capacity, say 60%, Sanofi must split expansion so that Danbury gets some of it, but this provision kicks in well before all 12 lines at Danbury are operation. We only know it is something short of full capacity. They redacted the % but from the structure of the sentence it is obvious that there is some % capacity that triggers SNY being allowed to build a facility.
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Post by nugjuice on Mar 3, 2015 14:35:23 GMT -5
So of course GS downgraded - putzes! Unbelievable. I guess it's like Austin wrote the other day. This is a "battlefield stock" where both sides are absolutely convinced they are right. I think Goldman Sachs will soon discover that Sanofi is much better at marketing diabetes drugs than Pfizer ever was. Still...how long will it be before Sanofi fires those thrusters? March? April? "I picked a bad day to quit sniffing glue." - Lloyd Bridges, AirplaneWant to know what's even funnier? Sanofi was the one who sold Exubera to Pfizer in the first place, for a cool $1.3 billion www.sanofi.us/l/us/en/layout.jsp?cnt=D87437C1-952B-448B-941A-43E37D666148Knowing that...doesn't it make you even more confident in Sanofi? They might come out of this looking like absolute geniuses
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Post by bradleysbest on Mar 3, 2015 14:54:07 GMT -5
They sure pulled a fast one on Pfizer! Not sure they were trying to but it worked out for them.
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