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Post by Deleted on May 12, 2017 10:53:40 GMT -5
"The same argument was made with the entire anti obesity sector. It is not happening fast enough.
Foreign approval
Classifying it as imminent is spin. Why not use the description of management. They are "on file and expect near term approval"
That being said, they do not have a partner.
Depending on what country, they may only have a registered agent. You should do some research on the approval process in various countries. If they have no partner, they will have to pay the registered agent, pay all costs of launch, etc. it costs money to launch.
A new country does not always mean the Robles that exist in the US evaporate."
This has to be the reason why Mannkind is under attack again.
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Post by akemp3000 on May 12, 2017 11:29:15 GMT -5
It's going to be enjoyable watching Osborne be so very wrong. Foreign approval in the Middle East isn't spin. It is imminent. Expect to hear details shortly and hopefully by or during the ASM.
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Post by agedhippie on May 12, 2017 13:25:50 GMT -5
It's going to be enjoyable watching Osborne be so very wrong. Foreign approval in the Middle East isn't spin. It is imminent. Expect to hear details shortly and hopefully by or during the ASM. I think if it was that imminent it would have been announced on the conference call ("we have filed for approval in <some ME country> and expect to hear the result within <n> months"). Easily done and it would have pushed the share price higher. Didn't happen though so the shorts take it as smoke and mirrors so the stock gets hammered again and the shorts get rich. |
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Post by Deleted on May 12, 2017 15:43:42 GMT -5
Os... expands on the middle-east topic in his latest piece:
"The Ministry of Health is the agency that controls what drugs can be imported. Any drug or medical device imported into UAE must be registered with the Ministry. It is possible for an unregistered drug to be imported, but there are sticking points there that require coordination with hospitals and a justification letter that the Ministry deems acceptable. Logic dictates that there is not a critical emergency for the importation of Afrezza, so the better assumption is that the drug is being filed for approval.
Whether the drug or device is registered or unregistered, the importing company must be registered. This brings into play a question. Is MannKind registered with the Ministry, and if not, how can importation be accomplished? Essentially MannKind would need to be an entity established in the UAE...OR...MannKind must find a person or company that is already a legal entity in the UAE."
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Post by akemp3000 on May 12, 2017 16:35:29 GMT -5
Os... expands on the middle-east topic in his latest piece: "The Ministry of Health is the agency that controls what drugs can be imported. Any drug or medical device imported into UAE must be registered with the Ministry. It is possible for an unregistered drug to be imported, but there are sticking points there that require coordination with hospitals and a justification letter that the Ministry deems acceptable. Logic dictates that there is not a critical emergency for the importation of Afrezza, so the better assumption is that the drug is being filed for approval. Whether the drug or device is registered or unregistered, the importing company must be registered. This brings into play a question. Is MannKind registered with the Ministry, and if not, how can importation be accomplished? Essentially MannKind would need to be an entity established in the UAE...OR...MannKind must find a person or company that is already a legal entity in the UAE." Good info. We will know very soon if Os is right and the Abu Dhabi shipment was spin... or not! Not that it matters but I've already cast my vote. |
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Post by Deleted on May 12, 2017 17:45:52 GMT -5
akemp3000 I generally agree with you, however, Wall Street has insiders in every country and they usually know ahead of everyone else of any major decision. Their confidence does create some anxiety.
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Post by dreamboatcruise on May 15, 2017 13:46:56 GMT -5
Os... expands on the middle-east topic in his latest piece: "The Ministry of Health is the agency that controls what drugs can be imported. Any drug or medical device imported into UAE must be registered with the Ministry. It is possible for an unregistered drug to be imported, but there are sticking points there that require coordination with hospitals and a justification letter that the Ministry deems acceptable. Logic dictates that there is not a critical emergency for the importation of Afrezza, so the better assumption is that the drug is being filed for approval. Whether the drug or device is registered or unregistered, the importing company must be registered. This brings into play a question. Is MannKind registered with the Ministry, and if not, how can importation be accomplished? Essentially MannKind would need to be an entity established in the UAE...OR...MannKind must find a person or company that is already a legal entity in the UAE." Good info. We will know very soon if Os is right and the Abu Dhabi shipment was spin... or not! Not that it matters but I've already cast my vote. I don't know about that. Over the years I've seen people hold onto their belief that things are "imminent" over incredibly long periods of time. Are you saying that if ASM comes and goes without announcement of shipment to Middle East you will assume it hasn't happened? You imply that you would accept it was fake news at some point. When exactly would be that point, or will you continue to think it "imminent" indefinitely. |
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Post by ilovekauai on May 15, 2017 14:41:20 GMT -5
I stopped reading anything that basher-writer "Spencer Osbourne" posts several years ago. IMO someone is paying him, most likely BP. Can't wait for the day when he is gone for good. Aloha.
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Post by akemp3000 on May 15, 2017 14:43:07 GMT -5
Good info. We will know very soon if Os is right and the Abu Dhabi shipment was spin... or not! Not that it matters but I've already cast my vote. I don't know about that. Over the years I've seen people hold onto their belief that things are "imminent" over incredibly long periods of time. Are you saying that if ASM comes and goes without announcement of shipment to Middle East you will assume it hasn't happened? You imply that you would accept it was fake news at some point. When exactly would be that point, or will you continue to think it "imminent" indefinitely. Fair question. Hard to say. I hope Matt provides an update regarding their hint of a middle east deal this week but certainly wouldn't be concerned or disappointed if it's delayed a few weeks. If so, I would have never gotten into biotechs  |
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Post by promann on May 15, 2017 14:45:02 GMT -5
Good info. We will know very soon if Os is right and the Abu Dhabi shipment was spin... or not! Not that it matters but I've already cast my vote. I don't know about that. Over the years I've seen people hold onto their belief that things are "imminent" over incredibly long periods of time. Are you saying that if ASM comes and goes without announcement of shipment to Middle East you will assume it hasn't happened? You imply that you would accept it was fake news at some point. When exactly would be that point, or will you continue to think it "imminent" indefinitely. I am in the camp of thinking the shipment was real after hearing at the 1st Q results that they are signed onto to a middle east Country. Once the news of what country it is breaks and if it happens to not be Dubai then thats when I will determine it was fake but until then I will think its a true shipment to Dubai. |
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Post by dreamboatcruise on May 15, 2017 14:47:45 GMT -5
I don't know about that. Over the years I've seen people hold onto their belief that things are "imminent" over incredibly long periods of time. Are you saying that if ASM comes and goes without announcement of shipment to Middle East you will assume it hasn't happened? You imply that you would accept it was fake news at some point. When exactly would be that point, or will you continue to think it "imminent" indefinitely. Fair question. Hard to say. I hope Matt provides an update regarding their hint of a middle east deal this week but certainly wouldn't be concerned or disappointed if it's delayed a few weeks. If so, I would have never gotten into biotechs And by "hint" of a middle east "deal" you mean explicit statement of filing for marketing approval with no mention of a deal? |
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Post by Deleted on May 16, 2017 4:01:33 GMT -5
I stopped reading anything that basher-writer "Spencer Osbourne" posts several years ago. IMO someone is paying him, most likely BP. Can't wait for the day when he is gone for good. Aloha. Osborne appears to softened his tone since the brief run-up. It will be interesting to see if Feroldi softens his stance. |
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