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Post by dreamboatcruise on Jun 5, 2018 1:29:20 GMT -5
That's not the Liquidia inhaler.
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Post by dreamboatcruise on Jun 5, 2018 0:34:55 GMT -5
stockwhisperer... there are a lot of hypotheticals. Listing them isn't an argument that they are likely. It's not tearing apart what you say, as you're basically just saying that things are possible. True enough. I too believe Mike is doing a fine job. Still likely we will have some significant further dilution based on what we can see from finances, where share price is currently and failed attempts to monetize IP despite concerted effort over past year with hired guns to do so. The company was in far worse shape before he became CEO, as he has alluded to. So even where we realistically are today (not wishful versions) is still good work on Mike's part.
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Post by dreamboatcruise on Jun 5, 2018 0:23:04 GMT -5
The Liquidia inhaler obviously has it's advantages ... with the size and shape of it, I can see it producing enough electricity to power my house. As long as you don't try to fit it in your pocket, or try to force the pieces together. What is the size of the Liquidia inhaler... no indication on that diagram? It's dry powder inhaler, many of which (such as asthma inhalers) are not much larger than dreamboat. And most dry powder inhalers aren't single use... probably could be dreamboat size if they had single use cartridges, though I assume that is considered less convenient than metered doses not requiring cartridges.
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Post by dreamboatcruise on Jun 4, 2018 22:39:34 GMT -5
Liquidia is a dry powder inhaler like TreT. What do you see as the advantage for MNKD that would win out over simply competing on price and splitting the market in some way with Liquidia having first mover advantage?
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Post by dreamboatcruise on Jun 4, 2018 19:47:38 GMT -5
It's mostly quotes from management reported accurately. It does present a management team projecting an air of confidence. As for meeting guidance... technically he did say that, though as early in the year as that was moved to the lower end of the previous range, reading between lines it would seem the probable range now includes possibility of being below $25M. The scripts as yet don't support hitting $25M by year end. It's possible, but a change in trajectory would need to materialize fairly soon now.Much of investing is making judgement about likely outcomes that can't be known with certainty. For many it appears that dilution is the likely path of further funding, and that view is bolstered significantly by recent MNKD history. I've heard no one make a convincing argument otherwise... as I'd simply characterize your position as "don't worry about it". 20 days until the oral presentation of the STAT study, and the poster presentation of total and severe hypoglycemia. "I'm also very pleased to announce that a team here within our medical group took the opportunity to look at data performed from a trial in Type 1 diabetes and assess not just the rates of hypoglycemia, but adjusted total and severe hypoglycemia rates comparing Technosphere Insulin with Insulin Aspart. And these data will be presented as one of approximately 100 late-breaking poster presentations at the American Diabetes Association." Like waiting for Christmas... can't we unwrap one present early? I do wonder what will be said about severe hypos, as previously it seems the data was determined to not be statistically significant. What is the "adjustment"?
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Post by dreamboatcruise on Jun 4, 2018 19:16:32 GMT -5
Yes, it would seem even under most scenarios of growing acceptance of Afrezza there would be a need to raise $100M+ more. International deals would just make small chips into that requirement. It is an excellent blog piece. What he is saying is accurate. it is what is known. Yes, money will be needed. The unknown, as to how that will be achieved is just that - unknown. Mike C says they will meet guidance for 2018. Folks can speculate from a negative perspective, as frequently done or just as easily from a positive perspective. It is all a guess anyway - until it happens. Thanks Mango & congrats - great job! It's mostly quotes from management reported accurately. It does present a management team projecting an air of confidence. As for meeting guidance... technically he did say that, though as early in the year as that was moved to the lower end of the previous range, reading between lines it would seem the probable range now includes possibility of being below $25M. The scripts as yet don't support hitting $25M by year end. It's possible, but a change in trajectory would need to materialize fairly soon now. Much of investing is making judgement about likely outcomes that can't be known with certainty. For many it appears that dilution is the likely path of further funding, and that view is bolstered significantly by recent MNKD history. I've heard no one make a convincing argument otherwise... as I'd simply characterize your position as "don't worry about it".
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Post by dreamboatcruise on Jun 4, 2018 19:02:03 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device. Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation. So even if it is deemed merely non-inferior I'd guess they could achieve market success. Form factor will be a huge advantage with TrepT. Also I believe the patients might not have to take 4 treatments a day with TrepT. The reason now is because the nebulizer is limited in the amount of drug that can reach the lung. Hopefully TrepT will give them more than enough medicine so they don't have to do it 4x a day. Regarding partnership deals? Well Liquidia got $200M+ for a pump that is attached 16 hours a day. If MNKD can get a clean Phase 3 READOUT they could get 4x that amount. That would really boil down to a question of the range of therapeutically beneficial blood concentration vs the half life. It would seem that if it were only an issue of how much could be delivered, patients could simply use the nebulizer for longer periods of time in fewer sessions and then not need to carry it around... so I suspect it isn't that simple. Here is an article discussing pk of Trep. It seems to indicate less than 1 hour half life when inhaled, though I find that hard to square with a much longer half life for IV (4.6h).
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Post by dreamboatcruise on Jun 4, 2018 18:40:09 GMT -5
mango - First congratulations on writing a blog piece. However, what you wrote below is the problem with MannKind, essentially no upfront money from partnerships. "Potential 2018 MannKind Non-Dilutive Sources of Capital and Catalysts 1. MannKind will receive a $2.2 million upfront payment from Cipla within 30 days of entering the agreement, with the potential to receive additional regulatory milestone payments, minimum purchase commitment revenue and royalties on Afrezza sales in India." Yes, it would seem even under most scenarios of growing acceptance of Afrezza there would be a need to raise $100M+ more. International deals would just make small chips into that requirement.
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Post by dreamboatcruise on Jun 4, 2018 18:26:30 GMT -5
It seems that the form factor would be much improved. The treatment needs to be done every 4 hours, so a lot easier with a pocket sized device.
Also seems there wouldn't be the same, perhaps misplaced, concern about lung safety as this API is already established for inhalation.
So even if it is deemed merely non-inferior I'd guess they could achieve market success.
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Post by dreamboatcruise on Jun 4, 2018 18:14:03 GMT -5
Is TreT a realistic drug MannKind wants to market or is it a proof of concept? For those that think TreT is marketable, what would a partner pay MannKind for the rights? What might be reasons it wouldn't be marketable?
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Post by dreamboatcruise on Jun 4, 2018 17:02:09 GMT -5
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Post by dreamboatcruise on Jun 3, 2018 22:52:54 GMT -5
I was at the ASM in 2017 and MNKD said they have to validate the stored insulin a couple times a year. They had to write off some insulin but it was a nominal amount. I believe they will use this insulin in the low cost international markets like India, China and Brazil. Also I'm not sure of the restrictions with Amphastar's insulin....can they use it for int'l markets? This has been discussed before, they cannot do that without creating major problems for their US production. The FDA have to approve ingredients as well as the product so if they use unapproved insulin they will contaminate the production line. I think there are some reasons to do with the insulin itself as well. Hate to question, but really using a different insulin you think contaminates the production line? or you've seen FDA taking that position?
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Post by dreamboatcruise on Jun 3, 2018 22:44:39 GMT -5
I'm as optimistic as anyone but it's still early to be passing around kudos. We've been there in the past thinking a party in Vegas was around the corner. That said, it does seem like it's about to turn for real this time. I'm most optimistic about the exponential learning curve that's about to take place. It starts with the former Chief Scientific Officer of the American Diabetes Association digging deeper into details than was apparently understood in the past. The results will then be spread to the ADA and Dr. Kendall's new Scientific Advisory Board which consists of some of the more influential leaders in the industry. Next up will be significant positive articles, all of which will then exponentially spread to endos and interested PCPs around the country as Mannkind participates in many of the conferences. Throw in a parallel marketing phase after the ADA and we might finally be on the path to where we want to go. I like Mike's plan! Sounds like a very good future to wish for.
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Post by dreamboatcruise on Jun 3, 2018 15:07:34 GMT -5
I think prescribing off label for pediatric use is one of the more common off label situations. Often drugs are first approved for adults, so docs are used to making judgement calls about ped use. I'd imagine with something like Afrezza it probably wouldn't be hard to find accommodating doc for older kids but might get more difficult for younger kids. But that's just a guess.
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Post by dreamboatcruise on Jun 3, 2018 15:01:04 GMT -5
Since it hasn't been mentioned for a while, I just thought I'd throw this out there. Could the stockpile of insulin that MNKD purchased some time ago, figure into international sales? For those new to the Board see: www.youtube.com/watch?v=8PcEHw5P71Y&t=41m17sI was at the ASM in 2017 and MNKD said they have to validate the stored insulin a couple times a year. They had to write off some insulin but it was a nominal amount. I believe they will use this insulin in the low cost international markets like India, China and Brazil. Also I'm not sure of the restrictions with Amphastar's insulin....can they use it for int'l markets? There are apparently some countries where MNKD cannot use Amphastar insulin per the agreement, but these excluded countries are redacted, so investors do not know what they are.
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