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Post by fldave007 on Jan 26, 2015 17:14:43 GMT -5
A little help please. What would the process be to use technosphere with other approved drugs? Certainly not full 3 phase trials again. Please any responses appreciated. Fldave007
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Post by 4allthemarbles on Jan 26, 2015 17:20:11 GMT -5
There still has to be trials.
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Post by hansmolo on Jan 26, 2015 17:31:27 GMT -5
Yeah, every new formulation will have to undergo human trials and then go through the FDA. Doesn't matter if it's a Technosphere formulation of an already approved drug.
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Post by jpg on Jan 26, 2015 19:04:28 GMT -5
Yes phase 1, 2 and 3. Some of them would probably be much faster then with Afrezza simply because the kinks have (hopefully) been ironed out and there is prior art.
JPG
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Post by gomnkd on Jan 26, 2015 19:08:48 GMT -5
The best option for. Mannkind is to license and get upfront/royalty. It doesn't make sense to spend a billion $ for a drug.
Intrexon has the model of signing collaboration agreements. market will price in higher multiple if they do that. I hope they don't send good money after bad.
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Post by jpg on Jan 26, 2015 19:18:35 GMT -5
The best option for. Mannkind is to license and get upfront/royalty. It doesn't make sense to spend a billion $ for a drug. Intrexon has the model of signing collaboration agreements. market will price in higher multiple if they do that. I hope they don't send good money after bad. I would say that the less partnerships they make now the better. With Afrezza they will relatively soon be able to afford a well thought out and self funded drug pipeline. I don't know if and when their peptide based pain drug is going to move forward but if that works as well as animal studies seem to show it working we are talking mega big blockbuster. I would hope that they keep it in house as long as possible. That type of drug would be a longer process to develop. Others that are known well studied drugs that would simply used Technosphere as a delivery system would be faster to get to market. JPG
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Post by mrhaigs on Jan 26, 2015 19:21:53 GMT -5
The best option for. Mannkind is to license and get upfront/royalty. It doesn't make sense to spend a billion $ for a drug. Intrexon has the model of signing collaboration agreements. market will price in higher multiple if they do that. I hope they don't send good money after bad. I would say that the less partnerships they make now the better. With Afrezza they will relatively soon be able to afford a well thought out and self funded drug pipeline. I don't know if and when their peptide based pain drug is going to move forward but if that works as well as animal studies seem to show it working we are talking mega big blockbuster. I would hope that they keep it in house as long as possible. That type of drug would be a longer process to develop. Others that are known well studied drugs that would simply used Technosphere as a delivery system would be faster to get to market. JPG Totally disagree. The more partnerships the better. We have no sales force. If we can get a big Pharma to fund trials, you would be crazy not to go for it. As long as the deal is fair. All profits from afrezza don't have to be sunk into "potential" applications that may or may not work.
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Post by jpg on Jan 26, 2015 19:29:22 GMT -5
I would say that the less partnerships they make now the better. With Afrezza they will relatively soon be able to afford a well thought out and self funded drug pipeline. I don't know if and when their peptide based pain drug is going to move forward but if that works as well as animal studies seem to show it working we are talking mega big blockbuster. I would hope that they keep it in house as long as possible. That type of drug would be a longer process to develop. Others that are known well studied drugs that would simply used Technosphere as a delivery system would be faster to get to market. JPG Totally disagree. The more partnerships the better. We have no sales force. If we can get a big Pharma to fund trials, you would be crazy not to go for it. As long as the deal is fair. All profits from afrezza don't have to be sunk into "potential" applications that may or may not work. It depends on the details (price, future revenue split etc). If some BP absolutely wants to make a deal and is willing to shovel money at us and give us good future revenue sharing: great and I'm all for it obviously. This being said at this point I don't think we would get the type of deals I think we will be able to get in a year or 2 though. I think and hope Mann will hold out for the best possible deals. JPG
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Post by shortslaver on Jan 26, 2015 19:29:49 GMT -5
These types of companies generate a ton of their valuation from pipelines and pipe dreams. Their pipeline would be built on a proven technology using proven medicines - very high probabilities of success.
However, their pipeline relies on Afrezza and more specifically the inhaled aspect of it to be considered safe, effective and popular and this will happen by users adopting it.
I expect an announcement for a rapid acting pain relief such as migraines to be announced in February this year. And possibly another target too.
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Post by biotec on Jan 26, 2015 20:02:28 GMT -5
The best option for. Mannkind is to license and get upfront/royalty. It doesn't make sense to spend a billion $ for a drug. Intrexon has the model of signing collaboration agreements. market will price in higher multiple if they do that. I hope they don't send good money after bad. I would say that the less partnerships they make now the better. With Afrezza they will relatively soon be able to afford a well thought out and self funded drug pipeline. I don't know if and when their peptide based pain drug is going to move forward but if that works as well as animal studies seem to show it working we are talking mega big blockbuster. I would hope that they keep it in house as long as possible. That type of drug would be a longer process to develop. Others that are known well studied drugs that would simply used Technosphere as a delivery system would be faster to get to market. JPG With what money? MNKD has no money for R&D! Unless you want to see another dilution in the stock? We are seeing what Afrezza does. Maybe in 3 yrs MNKD can pay for trials. Not anytime soon without a Big backup!
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Post by gomnkd on Jan 26, 2015 20:13:26 GMT -5
JPG The issue is that Mannkind may not have any money left to conduct new trials using TI. The milestone payments will go towards operating expense of Mannkind, contribution to partnership for building new factories, opex, other capex, ph4 trials, label expansion etc. The free cash flow from partnership will start flowing only after few years.
The last thing I want MNKD to do is to issue another 1/2 billion shares and dilute the heck out of common. One can excuse Al Mann for diluting as they didn't have a choice, but diluting now to risk capital is not prudent. I hope Al Mann balances helping Mankind and helping Mannkind.
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Post by dreamboatcruise on Jan 26, 2015 20:49:20 GMT -5
JPG The issue is that Mannkind may not have any money left to conduct new trials using TI. The milestone payments will go towards operating expense of Mannkind, contribution to partnership for building new factories, opex, other capex, ph4 trials, label expansion etc. The free cash flow from partnership will start flowing only after few years. The last thing I want MNKD to do is to issue another 1/2 billion shares and dilute the heck out of common. One can excuse Al Mann for diluting as they didn't have a choice, but diluting now to risk capital is not prudent. I hope Al Mann balances helping Mankind and helping Mannkind. The $175M credit line from SNY can be used to cover costs of launch. Somewhere there was an assertion that Matt believed this was a conservative number to cover all of MNKD's 35% responsibility of initial losses. I don't think anyone is advocating dilution to fund the pipeline, but with the milestone payments and the credit line they likely are in a strong position to at least push some candidates through early trials. I think I'd have faith in Al and company to know how to navigate best ROI regarding when to seek new partners.
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Post by EveningOfTheDay on Jan 26, 2015 20:59:57 GMT -5
JPG The issue is that Mannkind may not have any money left to conduct new trials using TI. The milestone payments will go towards operating expense of Mannkind, contribution to partnership for building new factories, opex, other capex, ph4 trials, label expansion etc. The free cash flow from partnership will start flowing only after few years. The last thing I want MNKD to do is to issue another 1/2 billion shares and dilute the heck out of common. One can excuse Al Mann for diluting as they didn't have a choice, but diluting now to risk capital is not prudent. I hope Al Mann balances helping Mankind and helping Mannkind. Management has repeated several times that dilution is not something they are considering at all, which means they already have a plan in place to expand the pipeline that does not include issuing shares. Whatever mistakes made on the past, or necessary painful steps taken to save the company, I believe management is been very straight forward and clear, at least in all those things they were willing to share, and Matt has clearly expressed his desire to keep operating in the same way.
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Post by brentie on Jan 26, 2015 21:14:39 GMT -5
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Post by trenddiver on Jan 26, 2015 21:33:48 GMT -5
I think it will be pain and weight loss drugs. 'I'm not worried about money.. Hakan says we will have plenty of available money for R & D. As for partnership or dilution, partnership is another form of dilution. In fact it can be a much more punitive form of dilution, especially when partnering at an early stage. I agree with JPG and Dreamboat. I trust Al to make the best deal at the right time, and would be fine with dilution, especially at higher prices.
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