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Post by prcgorman2 on Apr 6, 2019 9:00:54 GMT -5
Nope. I disagree. You were definitely trying to say the Cipla deal was dead because that’s what you said. And it was obviously misleading. I appreciate the fact that it was obvious. Makes it easier to point it out as cedafuntennis did, and I am too. What the article I read said about the ruling was that Cipla would have to conduct clinical trials.
Given that there has been corruption in the FDA (if you remember the FDA employee that was arrested and charged with misbehavior about 2 years ago), it would not at all surprise me that there is similar or worse in India. I mean even the Advisory Committee review that was required for Afrezza, and the 3rd set of clinical trials which were very clearly designed to make it nearly impossible to show superiority of Afrezza over RAA indicates further shenanigans.
Your posts and seanismorris posts also fall into my category which I’ve nicely called “shenanigans” as do many of the posters who’ve recently come out of the woodwork to say negative things about the company, and the management. I don’t believe for a moment that Proboards is immune from the same kind of trolls as dominate ST, and Yahoo! Conversations (and Yahoo! Message Boards before that). The only that hasn’t been attacked is Afrezza itself. Is that a sacred cow? Attack it too. Won’t matter to me or a lot of other people who know what we have here which is an excellent company with limited resources and the fastest and therefore best mealtime insulin in the world.
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Post by prcgorman2 on Apr 6, 2019 9:11:14 GMT -5
Here’s another thought on the outrageous suggestion of Afrezza in India being toast. Cipla’s market cap is almost $500 BILLION dollars. And, they’re in a country of more than a billion people with a very real diabetes problem (along with the rest of the planet).
If uvula or seanismorris think for one moment that a company with Cipla’s resources entered into the exclusive marketing agreement with the clause “only if we can get regulators to accept FDA prior approval” they’re smoking chronic ghanga.
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Post by agedhippie on Apr 6, 2019 10:41:57 GMT -5
Here’s another thought on the outrageous suggestion of Afrezza in India being toast. Cipla’s market cap is almost $500 BILLION dollars. And, they’re in a country of more than a billion people with a very real diabetes problem (along with the rest of the planet). If uvula or seanismorris think for one moment that a company with Cipla’s resources entered into the exclusive marketing agreement with the clause “only if we can get regulators to accept FDA prior approval” they’re smoking chronic ghanga. The problem isn't that Cipla couldn't do it, the question is what is their sense of urgency? Sanofi could have promoted Afrezza really aggressively, but it was a lower priority for them than getting customers switched over from Lantus to Toujeo and we saw how that ended. Where does Afrezza stand in Cipla's list of priorities/ At the moment they have spent $2M for the rights which is peanuts for them.
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Post by letitride on Apr 6, 2019 11:09:18 GMT -5
Here’s another thought on the outrageous suggestion of Afrezza in India being toast. Cipla’s market cap is almost $500 BILLION dollars. And, they’re in a country of more than a billion people with a very real diabetes problem (along with the rest of the planet). If uvula or seanismorris think for one moment that a company with Cipla’s resources entered into the exclusive marketing agreement with the clause “only if we can get regulators to accept FDA prior approval” they’re smoking chronic ghanga. I thought I smelled alot of that going around on this board lately. Thats why I prefer a nice aged bottle of rum it keeps me more grounded.
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Post by sportsrancho on Apr 6, 2019 11:27:13 GMT -5
I’m assuming Mike will clear that up on Monday. Along with some other issues. Maybe our runway for 2020... And I have to confess I have never gone into somebody’s profile and checked their sentiment 🤣 The only time I go to somebody’s profile is if I think they’re posting under two different names and then it’s to check their post history.
Looking forward to a good week for longs. A bad week for shorts, and an extra good week for us “Way too long’s!”
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Post by awesomo on Apr 6, 2019 12:36:49 GMT -5
Here’s another thought on the outrageous suggestion of Afrezza in India being toast. Cipla’s market cap is almost $500 BILLION dollars. And, they’re in a country of more than a billion people with a very real diabetes problem (along with the rest of the planet). If uvula or seanismorris think for one moment that a company with Cipla’s resources entered into the exclusive marketing agreement with the clause “only if we can get regulators to accept FDA prior approval” they’re smoking chronic ghanga. I like how you accuse people of spreading misleading iinformation but then you make this outrageous claim that Cipla’s market cap is $500 billion dollars. Check again, that market cap is in the Indian money denomination. The actual market cap in USD is $6.9 billion. What is the future of this partnership? Only Cipla and MannKind can answer that. The only thing we do know is that Cipla only put in $2.2M in upfront costs for this partnership, so it’s not like they are heavily invested into it.
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Post by prcgorman2 on Apr 6, 2019 12:54:28 GMT -5
Thank you awesomo. I stand corrected. I wondered after I said it if it was dollars or rupees but didn’t go back to check. My apologies for my own misinformation.
Regardless, the market and company are still both substantial and I stand by my assertion they’re serious buisness people there too and the article about the colloboration indicates they will be responsible for regulatory approval in country without qualification. It would be foolish of them to not take advantage of an opportunity to lean on FDA approval to fast-track the regulatory process and similarly it would be unlike the people who don’t want to see Mannkind and Afrezza be successful to not attempt to sway the ruling there as they did here in the US.
In any case, Dr. Castagna indicated the value of the India market was not likely large royalties but modest income and a way to help defray operational costs of Afrezza production.
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Post by uvula on Apr 6, 2019 17:19:28 GMT -5
Prcgornan, I NEVER said the cipla deal was dead. Never said it. Period. If you're going to attack someone at least do it honestly and don't distort things.
What I did say was that we don't know the details of the agreenent and therefore don't know if the fast track denial changes anything. Other people here are assuming cipla will now pay for a clinical trial. But none of us really know.
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Post by longliner on Apr 6, 2019 17:55:57 GMT -5
Prcgornan, I NEVER said the cipla deal was dead. Never said it. Period. If you're going to attack someone at least do it honestly and don't distort things. What I did say was that we don't know the details of the agreenent and therefore don't know if the fast track denial changes anything. Other people here are assuming cipla will now pay for a clinical trial. But none of us really know. True, what you did say was"for all we know the deal is now off"......
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Post by uvula on Apr 6, 2019 22:39:45 GMT -5
The fine print must define what happens if approval is denied. For all we know the deal is now off. Approval is never 100% guaranteed. This is my entire post. It is kind of negative. But the lack of clarity from mnkd gives me a bad feeling. I hope the ASM sheds some light on the status of India, etc.
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Post by cretin11 on Apr 7, 2019 3:45:41 GMT -5
The fine print must define what happens if approval is denied. For all we know the deal is now off. Approval is never 100% guaranteed. This is my entire post. It is kind of negative. But the lack of clarity from mnkd gives me a bad feeling. I hope the ASM sheds some light on the status of India, etc. Thanks uvula. Hopefully posters will stop attacking those who post info that is accurate but not super positive. And hopefully we do get some clarity on the India situation very soon. Cipla is responsible for approval expenses, that seems obvious from the language of the deal (and that’s a really good thing). What isn’t as obvious is what their intentions are in this regard.
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Post by matt on Apr 7, 2019 8:48:42 GMT -5
The problem isn't that Cipla couldn't do it, the question is what is their sense of urgency? Sanofi could have promoted Afrezza really aggressively, but it was a lower priority for them than getting customers switched over from Lantus to Toujeo and we saw how that ended. Where does Afrezza stand in Cipla's list of priorities/ At the moment they have spent $2M for the rights which is peanuts for them. That is the problem with any partnership or marketing relationship; there is always one party that has an extreme sense of urgency and for whom the deal might very well be do or die, while the other party is not nearly so engaged. When the interests of the companies are so well-aligned that they both need and want the deal to the same extent, that is usually the recipe for a merger rather than a distribution deal. MNKD will always have this problem, at least for the foreseeable future, because Afrezza needs a marketing / sales powerhouse to drive adoption and those companies with monster market presence have their choice of partners. A good place to check how important a deal is to a company is right on the home page where they list their most important therapeutic indications. Cipla has sixteen therapeutic categories listed (which these days is an extreme number for a company with roughly $2 billion in sales, most big pharmas are focused on five or fewer therapies) and on the diabetes pull-down they mention metformin, TZD, a sulfonylurea, statins, and others but no insulins. Instead, you have to read between the lines under the drug delivery menu where they mention dry powder inhalation without ever mentioning the type of drug they intend to deliver. That left me with the impression they view Afrezza as a developmental drug rather than something that fits with their current menu of marketed therapeutics; your read may be different.
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Post by prcgorman2 on Apr 7, 2019 9:24:48 GMT -5
Bam, bam, bam. I dub thee Fear, Uncertainty, and Doubt.
India is not a critical piece of the Mannkind puzzle.
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Post by sportsrancho on Apr 7, 2019 10:30:09 GMT -5
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Post by babaoriley on Apr 7, 2019 12:31:26 GMT -5
Another sub-forum should be established and perhaps quickly: MNKD Group Therapy
Could end up being the most popular and most important sub-forum we have.
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