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Post by rak5555 on Sept 4, 2014 9:15:06 GMT -5
The following is an attempt to create a list of potential Press Releases that we are fairly certain will occur within next 12 months. Note that I am avoiding highly speculative events such as buyouts and FDA approval of new technosphere applications (which will not occur w/in next 12 months). Please add/edit as you deem appropriate.
1. Cricket FDA Filing/Approval 2. Insulin stockpile FDA filing/approval 3. Factory capacity expansion 4. SNY partnership details 5. Phase 4 studies (e.g. weight gain, time of onset, hypo superiority, juvenile) 6. 12 Unit cartridge FDA filing/approval 7. Foreign country sale 8. European filing 9. Other sovereignty filings 10. Technosphere licensing agreements 11. "Al's New Process" 12. Global factory expansion 13. Milestone payments 14. Official adoption by insurance formularies
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Post by goyocafe on Sept 4, 2014 9:49:37 GMT -5
Maybe Sanofi will be more inclined to release these events as PRs. Time will tell.
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Post by mannmade on Sept 4, 2014 9:59:27 GMT -5
The following is an attempt to create a list of potential Press Releases that we are fairly certain will occur within next 12 months. Note that I am avoiding highly speculative events such as buyouts and FDA approval of new technosphere applications (which will not occur w/in next 12 months). Please add/edit as you deem appropriate.
1. Cricket FDA Filing/Approval 2. Insulin stockpile FDA filing/approval 3. Factory capacity expansion 4. SNY partnership details 5. Phase 4 studies (e.g. weight gain, time of onset, hypo superiority, juvenile) 6. 12 Unit cartridge FDA filing/approval 7. Foreign country sale 8. European filing 9. Other sovereignty filings 10. Technosphere licensing agreements 11. "Al's New Process" 12. Global factory expansion 13. Milestone payments
Don't forget the announcement of the official adoption by insurance formularies...  And maybe the direct purchase by that "Third World Country" that was referenced a couple of years back... |
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Post by rak5555 on Sept 4, 2014 10:13:15 GMT -5
Don't forget the announcement of the official adoption by insurance formularies... And maybe the direct purchase by that "Third World Country" that was referenced a couple of years back... :)I added your first suggestion. 2nd suggestion was covered by #7. Thanks. |
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Post by mnholdem on Sept 4, 2014 11:04:58 GMT -5
14. Official launch date for Afrezza 15. U.S. Sales for Afrezza
16. Afrezza sales guidance / forecasts by Sanofi (Sanofi data will be used for revenue guidance at MNKD earnings calls).
17. Medical journals advocating Afrezza as the "use first" drug for diabetes treatment. Sanofi will be pushing for a new paradigm for pre-diabetes treatment; possibly T1 & T2.
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Post by BlueCat on Sept 4, 2014 11:12:51 GMT -5
18. UK and EU Approval (in Phase III now?)
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Post by seanismorris on Sept 4, 2014 11:20:09 GMT -5
What do you mean by:
Cricket FDA Filing/Approval?
The Cricket inhaler is already patented. I don't think we'd see Afrezza paired with the Cricket inhaler...
Any new FDA filing would be something like 'some Technosphere pain med. plus the Cricket device' combo filing.
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Post by ashiwi on Sept 4, 2014 13:05:31 GMT -5
The Cricket inhaler has to be approved by the FDA for human trials to begin. Torrey Pines is currently running trials/studies with mice for migraine pain.
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Post by rak5555 on Sept 4, 2014 13:31:47 GMT -5
The Cricket inhaler has to be approved by the FDA for human trials to begin. Torrey Pines is currently running trials/studies with mice for migraine pain. Thanks ashiwi. I believe it was you that first advised me that cricket needed approval. I assume you learned this at the technosphere conference in Florida. |
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Post by ashiwi on Sept 4, 2014 15:56:51 GMT -5
Yes, It was Al Mann, Leone-Bay, and Jonathan Goldman who showed Spiro and myself the Cricket.
I spoke to someone at Torrey Pines 2 weeks ago and they indicated to me that FDA approval for the Cricket device is necessary before human trials can start. I just have no idea the status as of today. I need a volunteer to call MNKD and ask for an update on FDA approval for the Cricket.
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Post by spiro on Sept 4, 2014 16:27:38 GMT -5
Some of these future announcements will obviously be controlled by SNY, but quite a few can be generated by MNKD. I believe we will see two types of Technosphere announcements. Another company will contract with MNKD to use it's own drug formulation with Technosphere. In this instance MNKD will receive a small upfront payment with targeted milestones and royalties. The other company will fund all trials and expenses. Then we will see MNKD proceeding with it's own Techosphere project, where MNKD funds the early studies before partnering. The fun has yet to begin.
Spiro here, I can wait !
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Post by biotec on Sept 4, 2014 16:31:38 GMT -5
Some of these future announcements will obviously be controlled by SNY, but quite a few can be generated by MNKD. I believe we will see two types of Technosphere announcements. Another company will contract with MNKD to use it's own drug formulation with Technosphere. In this instance MNKD will receive a small upfront payment with targeted milestones and royalties. The other company will fund all trials and expenses. Then we will see MNKD proceeding with it's own Techosphere project, where MNKD funds the early studies before partnering. The fun has yet to begin. Spiro here, I can wait ! I dont see it Spiro. But if we get great news like that what will happen to the PPS? Go down to $4. |
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Post by brentie on Sept 4, 2014 17:53:54 GMT -5
Yes, It was Al Mann, Leone-Bay, and Jonathan Goldman who showed Spiro and myself the Cricket. I spoke to someone at Torrey Pines 2 weeks ago and they indicated to me that FDA approval for the Cricket device is necessary before human trials can start. I just have no idea the status as of today. I need a volunteer to call MNKD and ask for an update on FDA approval for the Cricket. That's rather disappointing. I wonder what happened to this... "Torrey Pines could begin human testing of new pain medication in 2013." www.tcpalm.com/business/torrey-pines-could-begin-human-testing-of-new-in |
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Post by spiro on Sept 4, 2014 18:19:42 GMT -5
19. Announcements for improved formulations for both Technosphere and Afrezza. This could be the slip of the tongue project.
20. Institutional ownership continues to expand.
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Post by kc on Sept 4, 2014 20:37:32 GMT -5
Somebody bought 1,188,940 shares tonight in AH. Either Sanofi or some institutional buyer. Yesterday two big blocks over 500,000 shares each. Tonight after hours. Something good is going to happen. Hopefully SHORTLY for us longs.
Spiro nailed it.
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And maybe the direct purchase by that "Third World Country" that was referenced a couple of years back... 
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