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Post by liane on Apr 20, 2015 16:03:21 GMT -5
Technosphere can adsorb a wide variety of small molecules, and they can be anionic (negatively charged), cationic (positively charged), or neutral. Obviously, clinical studies need to be done for each potential candidate, but the possibilities are extraordinary. The major limitation would be that the potential drugs do not harm lung tissue.
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Post by notamnkdmillionaire on Apr 20, 2015 17:00:42 GMT -5
I am starting to question the science too on this. Maybe the 'embarassment of riches' was a completely deluded, false statement. I don't know enough about the science at the molecular level but maybe technosphere is only good for insulin and nothing else. I believe Afrezza is make or break and the management has nothing up its sleeve. I thought they would have enough customers to support their valuation at a reasonable multiple to sales but now I am quite sure my theory is wrong. Al Mann doesn't care about returns and the current management is all too happy to gorge while they still can. My DD indicated a conservative $3B valuation but that assumed the management has the ability and motivation to make the company succeed. I no longer think that's true. I have zero hopes of closing my position in the green now. My only indecision is about what loss I will forgive myself. This board has been helpful source of info for me in the past but with the lack of any concrete information from the company, it's starting to become a cheerleading squad. The science is sound. The company has many years and ample data to show Technosphere works and is relatively safe. Only long term analysis will determine just how safe. There is also ample evidence of how Technosphere works with other drug molecules. The question is whether or not other biotechs really want to participate. We still wait for management to crap or get off the pot with regards to further technosphere candidates.
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Post by notamnkdmillionaire on Apr 20, 2015 17:01:57 GMT -5
Don't agree with your assumption but do FEEL your pain as a shareholder! Hopefully we get into our 2 minute offense (DTC) & MNKD announces a TS partnership or plan that will get us into the Red Zone! They already made the announcement that was supposed to get us into the END ZONE last summer. Not happening with this current rollout Oh, they got into the end zone. The problem is that instant replay is taking for ever to determine if it truly was a touch down.
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Post by bradleysbest on Apr 20, 2015 17:02:18 GMT -5
Hakan did say other new TS opportunities would not take as long to get to market. Hope he is right.
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Post by BlueCat on Apr 20, 2015 19:12:13 GMT -5
I think it will go quicker.
But imagine you are Old Mann and Hakan at the bargaining table.
Wouldn't it be best to be able to say:
1. Technosphere platform already vetted and approved by FDA, and now actively and successfully used by patients
2. Techhnosphere can breathe new life into your soon-off-patent drugs
3. Technosphere is a proven platform for commercial success - and we have an example adoption curve and introduction process to show as an example and proof point.
Imagine how much stronger their negotiating power would be? A few more months of adopter testimonial (essentially, field testing to prove demand and no problematic side effects), and the eventual hockey-stick rise in scripts ... and ...
Whammo! Price ticket to use/license TS just went way up.
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Post by mnholdem on Apr 21, 2015 7:08:38 GMT -5
Hakan also stated that management has already chosen the API's for their next developmental drugs.
Either branded or generic API's (i.e. branded Imitrex vs generic Sumatriptan for migraines) could have been chosen. A branded API would mean a partnership with the pharma that owns the brand. Generic API's may end up resulting in a broader range of partnership options solely for sales & marketing.
Regardless, if the API's have already been FDA approved, the regulatory approval cycle to market it using a novel delivery system (pulmonary) should flow through regulatory approval faster, especially since the delivery system - MannKind's Technosphere - has also been FDA approved.
Also, keep in mind that in addition to "Speed to Market" Hakan also stated the drugs selected have "a large market". This is the second criteria that was used in their selection of MannKind's next pipeline developments.
I am making these associations:
1. Faster Approval = Lower Cost of Development 2. Larger Market = Lucrative / Future Cash Generator
What remains to be seen is how much of the development costs the pharmaceutical company/companies will pony up in the form of upfront payments. MannKind must first have the cash to either develop that BP's brand or it's own inhaled "generic" that BP's will agree to market & sell for a cut of the profits.
Either way, I see the road into the future holds a huge potential that MannKind Corporation will be swimming in cash.
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Post by Deleted on Apr 21, 2015 7:39:28 GMT -5
mnh, To do a trial on Imitrex / Sumatriptan: How many sights and participants would be needed and how much time to do trial? How do they do efficacy? Trial participants who suffer from migraines take it when they have headache and see how long it takes to work and how complete pain relief is? Hakan also stated that management has already chosen the API's for their next developmental drugs.
Either branded or generic API's (i.e. branded Imitrex vs generic Sumatriptan for migraines) could have been chosen. A branded API would mean a partnership with the pharma that owns the brand. Generic API's may end up resulting in a broader range of partnership options solely for sales & marketing.
Regardless, if the API's have already been FDA approved, the regulatory approval cycle to market it using a novel delivery system (pulmonary) should flow through regulatory approval faster, especially since the delivery system - MannKind's Technosphere - has also been FDA approved.
Also, keep in mind that in addition to "Speed to Market" Hakan also stated the drugs selected have "a large market". This is the second criteria that was used in their selection of MannKind's next pipeline developments.
I am making these associations:
1. Faster Approval = Lower Cost of Development 2. Larger Market = Lucrative / Future Cash Generator
What remains to be seen is how much of the development costs the pharmaceutical company/companies will pony up in the form of upfront payments. MannKind must first have the cash to either develop that BP's brand or it's own inhaled "generic" that BP's will agree to market & sell for a cut of the profits.
Either way, I see the road into the future holds a huge potential that MannKind Corporation will be swimming in cash.
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Post by mnholdem on Apr 21, 2015 8:19:47 GMT -5
You'd be better off asking a trial physician those questions. I'm an executive for several medical device companies, but have never gone through an FDA approval process for a drug.
Incidentally, the sumatriptan was specifically mentioned in the MannKind patent related to pain relief. Several examples were provided in that documentation where migraine pain, dental pain and back pain "disappeared" completely within minutes. I've never been 100% certain whether examples listed as embodiments within a patent are hypothetical or factual patient results.
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Efficacy? I would think the FDA would weigh in the data that an FDA-approved API is effective as a treatment.
Your question about how many sites and patients are needed to determine how efficacious an API is via pulmonary delivery... well, that's the $1 billion question, isn't it!
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Post by dstevenson on Apr 21, 2015 8:37:44 GMT -5
Got a hold of Matt, didn't really say much to boost my confidence but I am still in this thing with you guys.
I know he can't say much anyways due to SEC so we'll see what happens during the annual meeting. I really want Togo...
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Post by Deleted on Apr 21, 2015 8:42:58 GMT -5
Thanks, for some reason I thought your background was Rx. You'd be better off asking a trial physician those questions. I'm an executive for several medical device companies, but have never gone through an FDA approval process for a drug.
Incidentally, the sumatriptan was specifically mentioned in the MannKind patent related to pain relief. Several examples were provided in that documentation where migraine pain, dental pain and back pain "disappeared" completely within minutes. I've never been 100% certain whether examples listed as embodiments within a patent are hypothetical or factual patient results.
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Efficacy? I would think the FDA would weigh in the data that an FDA-approved API is effective as a treatment.
Your question about how many sites and patients are needed to determine how efficacious an API is via pulmonary delivery... well, that's the $1 billion question, isn't it!
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Post by rockstarrick on Apr 22, 2015 9:58:36 GMT -5
I am starting to question the science too on this. Maybe the 'embarassment of riches' was a completely deluded, false statement. I don't know enough about the science at the molecular level but maybe technosphere is only good for insulin and nothing else. I believe Afrezza is make or break and the management has nothing up its sleeve. I thought they would have enough customers to support their valuation at a reasonable multiple to sales but now I am quite sure my theory is wrong. Al Mann doesn't care about returns and the current management is all too happy to gorge while they still can. My DD indicated a conservative $3B valuation but that assumed the management has the ability and motivation to make the company succeed. I no longer think that's true. I have zero hopes of closing my position in the green now. My only indecision is about what loss I will forgive myself. This board has been helpful source of info for me in the past but with the lack of any concrete information from the company, it's starting to become a cheerleading squad. There is quite a bit of information out there google.com/patents/WO2013016754A1?cl=en
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Post by rockstarrick on Apr 22, 2015 10:03:42 GMT -5
I am starting to question the science too on this. Maybe the 'embarassment of riches' was a completely deluded, false statement. I don't know enough about the science at the molecular level but maybe technosphere is only good for insulin and nothing else. I believe Afrezza is make or break and the management has nothing up its sleeve. I thought they would have enough customers to support their valuation at a reasonable multiple to sales but now I am quite sure my theory is wrong. Al Mann doesn't care about returns and the current management is all too happy to gorge while they still can. My DD indicated a conservative $3B valuation but that assumed the management has the ability and motivation to make the company succeed. I no longer think that's true. I have zero hopes of closing my position in the green now. My only indecision is about what loss I will forgive myself. This board has been helpful source of info for me in the past but with the lack of any concrete information from the company, it's starting to become a cheerleading squad. There is quite a bit of information out there google.com/patents/WO2013016754A1?cl=en ir.amphastar.com/events.cfm
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Post by rockstarrick on Apr 22, 2015 10:10:53 GMT -5
Technosphere Platform AFREZZA (insulin) MKC253 (GLP-1) MKC180 (obesity compound) Cancer Immunotherapy MKC1106-MT MKC1106-PP MKC1106-NS Cancer Drugs MKC204 (IRE-1 inhibitor) In addition to our Technosphere platform, we are developing therapies for the treatment of different types of cancer. We have conducted Phase 1 clinical studies of two immunotherapy product candidates, MKC1106-PP and MKC1106-MT, and are preparing to initiate a Phase 2 study of MKC1106-MT in patients with advanced melanoma. We are also conducting preclinical studies of a drug candidate, MKC204, that may have the potential to treat certain malignancies and inflammatory diseases Less
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