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Post by Deleted on Feb 8, 2016 13:33:57 GMT -5
Does anyone know the true cost of the clinical trials? Matt has doged the question and not given it a $$ amount during the conference call or JPM conference. He keeps saying it wont be much. But I have read differently however I have no idea if what I have read has an agenda of some sort pediatric trial is 46 patients.. that would be minimal - 20 to 25K per enrolled patient? 1 to 2 mil? the biggest cost is the safety trial - but that doesnt start until later in the year Yes thats what I meant the safety trial. He has doged the $$ amount twice now. What do you think it will cost??? |
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Post by nylefty on Feb 8, 2016 14:39:55 GMT -5
I'm sure I'll be shouted down by the bashers for posting the following, but here's how MNKD stock has done in the past 30 days compared to biotechs in general: MNKD: UP 33.93 percent IBB: DOWN 18.12 percent only if you started a position in the last 30 days and I dont need to even bash.. true Actually, whether you bought Mannkind stock years ago or 30 days ago, the value of your shares increased by nearly 34 percent in the last 30 days. |
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Post by peppy on Feb 8, 2016 15:05:53 GMT -5
pediatric trial is 46 patients.. that would be minimal - 20 to 25K per enrolled patient? 1 to 2 mil? the biggest cost is the safety trial - but that doesnt start until later in the year Yes thats what I meant the safety trial. He has doged the $$ amount twice now. What do you think it will cost??? I think the cost may be the cost of the afrezza. Sanofi should have the six to eight week done. When I looked at this study months ago, it said it was started, now saying recruiting. Depends on how far Sanofi goes? Detailed Description:
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
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Post by Deleted on Feb 8, 2016 15:11:57 GMT -5
Yes thats what I meant the safety trial. He has doged the $$ amount twice now. What do you think it will cost??? I think the cost may be the cost of the afrezza. Sanofi should have the six to eight week done. When I looked at this study months ago, it said it was started, now saying recruiting. Depends on how far Sanofi goes? Detailed Description:
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
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Post by agedhippie on Feb 8, 2016 15:21:34 GMT -5
Yes thats what I meant the safety trial. He has doged the $$ amount twice now. What do you think it will cost??? I think the cost may be the cost of the afrezza. Sanofi should have the six to eight week done. When I looked at this study months ago, it said it was started, now saying recruiting. Depends on how far Sanofi goes? Detailed Description:
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
I think Reverselo is talking about the large scale lung cancer study that was the fourth FDA requirement rather than the pediatric safety study. The lung study is not listed on Clinical Trials and will be expensive since it is multi year. |
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Post by Deleted on Feb 8, 2016 16:08:52 GMT -5
I think the cost may be the cost of the afrezza. Sanofi should have the six to eight week done. When I looked at this study months ago, it said it was started, now saying recruiting. Depends on how far Sanofi goes? Detailed Description:
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.
I think Reverselo is talking about the large scale lung cancer study that was the fourth FDA requirement rather than the pediatric safety study. The lung study is not listed on Clinical Trials and will be expensive since it is multi year. Yes, this. He keeps dodging the question and has stated it will not cost much. What does something like this cost? |
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Post by factspls88 on Feb 8, 2016 18:50:04 GMT -5
The three biggest issues are cash, cash, and cash. Without more of it, and very soon, none of the ideas Matt is working on will ever happen. Matt was clear that he is looking at non-exclusive deals and foreign deals for distribution of Afrezza, something that all but guarantees that no big pharma will participate. I can't remember a single big pharma deal that has gone down since the 1980's where the partner did not have global exclusivity, and part of the reason the small companies can get upfront payments is because they are willing to give global exclusivity. The kind of local or regional deals that may happen now might sell some Afrezza, but it won't come with a big initial chunk of cash and sales will take a while to get going. TS is even more unlikely to generate big up-front chunks of cash. There is just too much uncertainty in drug delivery deals until the formulation work is complete and the regulatory hurdles are identified. There is a big difference between having an idea to use TS and actually having a working formulation to use TS; look how long it took MNKD to get insulin approved. Most of those efforts fail, that is the nature of the R&D business, and why almost all drug delivery deals are backloaded with milestones and royalties that are paid after the drug is approved. Which begs the question of where the cash will come from to keep MNKD alive, and for that I don't have a good answer. The financial markets are not very friendly at the moment, the balance sheet cannot tolerate any more senior debt, and I don't see any quick hits for Afrezza or TS that will generate cash. Unless Al wants to increase his investment, all the sources of cash MNKD can still tap are pretty awful people to deal with. My sense is that they need to partner soon or sell something. It will be real telling if no other BP steps up to offer a partnership for Afrezza in my opinion. Not sure if that means no one wants to touch it because it is not perceived as viable or if it's that we're sitting on the 100 mpg carburetor that big business wants to keep out of the market. I certainly cannot imagine someone stepping up to get involved with the best treatment for diabetes in decades. I agree wholeheartedly they that need to partner soon. I don't see how Mannkind can afford to market Afrezza the way it needs to be marketed. In addition, they simply don't have the talent in the company, and I am concerned that they won't be able to attract the talent given their financial condition. DeSisto was game because he was already retired and probably couldn't resist the challenge, but how many others like him are out there with the resume he had. I am hoping that there will be a potential partner that simply can't resist offering a reasonable premium to the low price at which Mannkind is trading. |
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Post by agedhippie on Feb 8, 2016 21:49:05 GMT -5
I think Reverselo is talking about the large scale lung cancer study that was the fourth FDA requirement rather than the pediatric safety study. The lung study is not listed on Clinical Trials and will be expensive since it is multi year. Yes, this. He keeps dodging the question and has stated it will not cost much. What does something like this cost? The requirement is a 8,000 to 10,000 person randomized trial and these cost from $20,000 to $40,000 per head. As this is a 5 year trial I would guess a minimum of $200 million but it could easily be more. However while there is some front loading of costs it would be nowhere near $200 million in the first year. |
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Post by mnholdem on Feb 8, 2016 21:54:38 GMT -5
I think your per head estimate is too high, as the long-term safety trial involves basic lung measurements only every six months.
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Post by agedhippie on Feb 8, 2016 22:38:29 GMT -5
I think your per head estimate is too high, as the long-term safety trial involves basic lung measurements only every six months. It's possible. I got those numbers from a 2013 Forbes article specifically on the cost of follow up trials. I also had a number from a paper analyzing follow on trials costs back in 2007 saying $15,000 to $30,000 so the numbers seem reasonable I think. In both cases they were for diabetes drugs. To me the numbers seem low. Taking $20,000 as a cost that is $4,000 per year per head. This is more than a lung safety trial it is a randomized lung, CVD, and cancer (not just lung cancer) trial. The overhead will not be trivial, it is more like a five year phase 3 trial! |
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Post by Deleted on Feb 8, 2016 22:46:12 GMT -5
Yes, this. He keeps dodging the question and has stated it will not cost much. What does something like this cost? The requirement is a 8,000 to 10,000 person randomized trial and these cost from $20,000 to $40,000 per head. As this is a 5 year trial I would guess a minimum of $200 million but it could easily be more. However while there is some front loading of costs it would be nowhere near $200 million in the first year. I have read the 200-300 million mark from others also but dont know their intentions. What Matt does not do is provide any color and refuses to put a dollar amount on it. Its really bothering me. |
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Post by Deleted on Feb 8, 2016 22:46:43 GMT -5
I think your per head estimate is too high, as the long-term safety trial involves basic lung measurements only every six months. Why do you think Matt keeps avoiding answering the questions and keeps saying it wont be too much. |
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Post by mnholdem on Feb 9, 2016 8:28:27 GMT -5
Not sure about Matt's mindset, but I'd guess that it may be because the protocols that Sanofi/MannKind were meeting with the FDA about either haven't been finalized yet or because Sanofi hasn't transitioned all the trial data (including preliminary cost estimates) back to MannKind yet. I estimate the FDA-mandated Afrezza 5-year post-marketing lung safety trial costs will be no higher than $1,000yr/patient or $8M-$10M per year. Total trial around $40M-$50M.  |
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Post by Deleted on Feb 9, 2016 9:03:04 GMT -5
Not sure about Matt's mindset, but I'd guess that it may be because the protocols that Sanofi/MannKind were meeting with the FDA about either haven't been finalized yet or because Sanofi hasn't transitioned all the trial data (including preliminary cost estimates) back to MannKind yet. I estimate the FDA-mandated Afrezza 5-year post-marketing lung safety trial costs will be no higher than $1,000yr/patient or $8M-$10M per year. Total trial around $40M-$50M. I can agree with that. He could easily say that. I feel like he knows how bad it will sound given their current financial situation. These are things they should be transparent about. |
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Post by agedhippie on Feb 9, 2016 18:13:56 GMT -5
In the end the exact numbers are not that important because any dispute is settle by arbitration and not by trial.
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