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Post by mnkdnewbie on Aug 3, 2017 11:03:19 GMT -5
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Post by esstan2001 on Aug 3, 2017 11:13:57 GMT -5
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: Yes Device Product Not Approved or Cleared by U.S. FDA: Yes ??Pediatric Postmarket Surveillance of a Device Product: No Product Manufactured in and Exported from the U.S.: Yes I think that red yes is an error... but I like the last Yes. |
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Post by dh4mizzou on Aug 3, 2017 11:22:14 GMT -5
Wish the 3rd row of this were a lot sooner.....
Estimated Enrollment: 25
Anticipated Study Start Date: July 31, 2017
Estimated Study Completion Date: February 1, 2022
Estimated Primary Completion Date: August 1, 2021 (Final data collection date for primary outcome measure)
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Post by dreamboatcruise on Aug 3, 2017 11:56:28 GMT -5
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: Yes Device Product Not Approved or Cleared by U.S. FDA: Yes ??Pediatric Postmarket Surveillance of a Device Product: No Product Manufactured in and Exported from the U.S.: Yes I think that red yes is an error... but I like the last Yes. I don't believe the DiAS "artificial pancreas" is approved. |
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Post by oldfishtowner on Aug 3, 2017 12:04:44 GMT -5
From a quick search of the literature, the Yale research appears to be part of the JDRF-initiated AP (artificial pancreas) Consortium (see: www.medpagetoday.com/Blogs/DiabetesDiscovery/51124 ). I am not sure if the DiAS (diabetes assistant) is a generic term or represents a specific design the consortium has developed, but there is a paper by the University of Virginia and Montpellier University Hospital describing a/the DiAS (see: www.mdpi.com/2079-9292/3/4/609/pdf ). The description on the UVa website of work they have done on the DiAs seems to imply that the term refers to the smart-phone-based system they have developed ( med.virginia.edu/diabetes-technology/). By the way, note the decsription of Afrezza as "inhaled insulin with ultra-fast kinetics" in the Yale study description on clinicaltrials.gov. |
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Post by jay1ajay1a on Aug 3, 2017 12:28:29 GMT -5
But we are going BK on the 7th, how can we start a study? It is all over ST.
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Post by dreamboatcruise on Aug 3, 2017 12:31:46 GMT -5
But we are going BK on the 7th, how can we start a study? It is all over ST. Yale is going bankrupt according to some on ST? Seems unlikely. |
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Post by madog365 on Aug 3, 2017 12:33:29 GMT -5
Yes i heard Mannkind will be bankrupt within the next few days, i heard it here on Proboards - it must be true.
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Post by compound26 on Aug 3, 2017 12:42:33 GMT -5
Yes i heard Mannkind will be bankrupt within the next few days, i heard it here on Proboards - it must be true. Yes, I recall reading that. The date was predicted to be Thanksgiving 2016 and then updated to be August 15, 2017. I was extremely nervous before Thanksgiving 2016 and now again as we are approaching August 15, 2017.  |
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Post by dreamboatcruise on Aug 3, 2017 12:53:23 GMT -5
Yes i heard Mannkind will be bankrupt within the next few days, i heard it here on Proboards - it must be true. Show me... link please. |
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Post by madog365 on Aug 3, 2017 13:14:19 GMT -5
Yes i heard Mannkind will be bankrupt within the next few days, i heard it here on Proboards - it must be true. Show me... link please. Only since you asked nicely here. This is just my favorite one, not the only one. The next bankrupcty date is aug 14th. mnkd.proboards.com/post/109046 |
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Post by nadathing on Aug 3, 2017 13:17:31 GMT -5
Holy cow! A 4 year study?  Better enroll more than 25 participants. I would imaging some will move or lose interest along the way. |
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Post by dreamboatcruise on Aug 3, 2017 13:29:04 GMT -5
Only since you asked nicely here. This is just my favorite one, not the only one. The next bankrupcty date is aug 14th. mnkd.proboards.com/post/109046I'd argue that isn't a few days. Others here are asserting that someone is claiming bankruptcy will be declared on the conference call and I certainly haven't seen that myself here. Additionally, Matt made that observation (very useful insight from his business experience) about the timing of a bankruptcy if indeed they needed to do it before the recent deal with Deerfield, which seems to have kicked the can down the road a bit. Matt made reference to other options for financing such as a rights offering. You are misrepresenting his post if you claim he said Aug 14th bankruptcy filing was inevitable, or even the likely route. He merely stated from his expertise that unless there was some change in the finances, that date would be a logical one from a logistics standpoint for MNKD to decide to file if additional funding could not be obtained. I can't speak for Matt, but given the terms of the deal with Deerfield it appears they are exploring options in a search that will last beyond Aug 14th, so unlikely a bankruptcy would be filed then. The risk of bankruptcy has certainly not vanished, however. Don't believe people saying it here... the company says it in their SEC filings. |
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Post by peppy on Aug 3, 2017 13:37:26 GMT -5
Only since you asked nicely here. This is just my favorite one, not the only one. The next bankrupcty date is aug 14th. mnkd.proboards.com/post/109046I'd argue that isn't a few days. Others here are asserting that someone is claiming bankruptcy will be declared on the conference call and I certainly haven't seen that myself here. Additionally, Matt made that observation (very useful insight from his business experience) about the timing of a bankruptcy if indeed they needed to do it before the recent deal with Deerfield, which seems to have kicked the can down the road a bit. Matt made reference to other options for financing such as a rights offering. You are misrepresenting his post if you claim he said Aug 14th bankruptcy filing was inevitable, or even the likely route. He merely stated from his expertise that unless there was some change in the finances, that date would be a logical one from a logistics standpoint for MNKD to decide to file if additional funding could not be obtained. I can't speak for Matt, but given the terms of the deal with Deerfield it appears they are exploring options in a search that will last beyond Aug 14th, so unlikely a bankruptcy would be filed then. The risk of bankruptcy has certainly not vanished, however. Don't believe people saying it here... the company says it in their SEC filings. good one madog. I remember that post. |
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Post by tchalaa on Aug 4, 2017 3:05:23 GMT -5
#What are our Opportunities?
It is interesting to see these many news signs, but let us stay focus.
I was ready for a rollercoaster, but not combined with a marathon of this magnitude; Yes, because simply passing the critical line of the FDA was a though one, now getting to market, mass distribution, seems to be at least as though as the two CRL we got before finally getting through.
It is true, we know they were false allegations made by the Famous troll Shrekli but the damage is impacting us till today beside some management inefficiencies.
The Study is NICE most especially because it is sponsored by YALE not mannkind. Currently we, MNKD, are soffucating under the weight of our potentials.
#What is our strength? One of is kind Product: Inhaled Insulin Afrezza with better Output and Outcome such as better life quality base on users anecdots.
#What are our weaknesses? Very low market presence -> Very low penetration still at the "Innovators phase" 0-850 (-> the best will be to have a sharp early adopters phase 850-4500 to brake the early Majority 4500-12500)
#What are our threads: Cashflow challengies, Extremely bad potential valuation on the stockmarket manipulation to it finest, Extremely agressiv competitiors
We should start HOPING to celebrate only atleast when the above mentioned Threads, won't be there anymore. May be as weaknesses before getting off for good of our High Priority To-do-list.
Nothing against opportunities, hopes, but for the past 5 years I have been through this and some great board members for the past 10 years and more.
The science is the first step greatly achieved, hence as a company NOW the cashflow MOST come, not still "will come" (Hakan -> Al. Mann -> M. Pfeffer -> M. Castagna!!!!! ... )
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Better enroll more than 25 participants. I would imaging some will move or lose interest along the way.
