|
Post by nadathing on Aug 21, 2013 21:44:10 GMT -5
Hi Douge. You are correct in stating that needles are a lot less painful these days. Last night I had dinner with a lady who is T1. I am T2 and on Bydureon which is one shot a week. I asked her about her regiment and she said Metformin and Glucophage. I really couldn't believe she wasn't on insulin so I asked her about it and her response was " I hate needles". Perhaps I am wrong, but I thought all T1's were on insulin. If this lady is that adverse to even the thought of injections, even though they are relatively pain free, I would guess there are many who are of the same mindset. If I am incorrect about all T1's reqyuiring insulin will someone please correct me and offer an explanation how they can get by without it. Thanks, Nada.
|
|
|
Post by nadathing on Aug 21, 2013 21:50:46 GMT -5
"Pricing: Even relatively small increases in the cost per patient will add up to massive additional costs due to the millions of patients that potentially will make use of such new products".
My insurance company is willing to pay more for my Bydureon than other means of treatment because the benefits are greater than the risk of not treating. My company has even assigned a LPN to call me twice a month to discuss health matters. The new thought, for which I am grateful, is forward thinking: Pay now or risk huge health care costs in the future from failure to adhere to treatment.
|
|
|
Post by wellsbro on Aug 21, 2013 22:24:29 GMT -5
I respectfully disagree. Think was likely premature until results announced. Perfect timing (in my opinion) to announce hiring of GH (likely had GH deal in place month before results announced) Mnkd has likely had serious conversations w a few potential partners but think we all knew (or should have) that best partner and best deal would not happen until all legit contenders have been evaluated. And mnkd said some serious potential partners would wait to discuss until after p3 results announced. Sent from my iPad Here, in the last CC they announced they hired Greenhill to start a four month process once this process is finished and partners are narrowed down it will take on average an additional 3-5 months to complete a partnership if one is seen. August plus 4 months leads us to December plus three to five months gives us January or February before we even hear about news of a partnership in my belief. So at the very least we are 4 months away (as you have stated it is a long process and MNKD would and should way out every possible scenario), even if MNKD had existing conversations with possible partners. Note that Al Mann also drives a hard bargain and is majority share holder. MNKD is in a strangely disadvantaged yet advantaged position. They have a manufacturing plant, the insulin, the patents, the device and the drugs but lack the cash and marketing team and have yet to gain approval. What can a partner offer MNKD? Milestone payments and a marketing team but why step in when approval is not known and commercial success is highly questionable. There are still a lot of road blocks ahead. A large bio would much rather buy Mannkind then partner with them in my opinion. Mannkind still has a lot to prove. While Mannkind might be a great speculative play for an investor this does not translate to a successful company. Obvious prospects for physical growth in a business do not translate into obvious profits for investors. Mannkind has no revenue at all mind you! Yes this is common for biotechs but remember operations for profit should be based not on optimism but on arithmetic.
|
|
|
Post by wellsbro on Aug 21, 2013 22:34:23 GMT -5
Sorry - still getting used to this board. Wanted to clear up that Hakan never said a "four month" partnering process. He said "formal" partnering process - so we really did not get a time frame on this call. They have said earlier this year that it could be before or after resubmission, and Al has said he expects it before the end of the year.
|
|
|
Post by clos22 on Aug 21, 2013 23:15:48 GMT -5
en.wikipedia.org/wiki/Inhalable_insulinThank you for proving my point. They're both classified and categorized as inhalable insulin. For insulin-treated patients with diabetes, the needle required for a subcutaneous (sc) injection of insulin is the symbol for their disease. The pain associated with this route of insulin administration was reduced substantially in the last decades by the development of modern needles with their extremely sharp tips, a polished surface, and a coating that allows easy penetration into the skin. Therefore, once patients experience that a sc injection is more or less free of pain in most cases (when you do not hit a nerve ending directly), this is no longer a hurdle for most patients.
|
|
|
Post by clos22 on Aug 21, 2013 23:17:45 GMT -5
I'm sorry Douge but you'll have to do a better job of convincing me. I think we both agreed already on the classification and yes both are inhaled. What about the actual drug and the PK Profile? Would love to paste a slide here but I can't. It's not about how the drug gets into the body it's about how well the drug works. Lets discuss this in more detail. I really want to hear what you have to say about the two drugs. Please continue. The PK profile is different but both are inhaled into the lungs. Both need a device to use. Both are more expensive in price. Afrezza's insulin is broken into its monomeric components, resulting in significantly shorter time to peak insulin levels (14 minutes for Afrezza and 49 minutes for Exubera). This monomeric formulation is reputed to more closely mimic the natural insulin response of healthy individuals as well as decrease the risk of hypoglycemia and is weight neutral. Stevie, please also respond to my comment about Afrezza's pricing and how that will be a barrier to inhalable insulin becoming adapted (as I believe MNKD approval is likely). Also, although Pfizer stopped producing/manufacturing Exubera, they still have the rights to make it. If inhalable market catches on Exubera can theoretically once again be produced and compete with Afrezza for market share.
|
|
|
Post by StevieRay on Aug 22, 2013 8:08:41 GMT -5
Sorry - still getting used to this board. Wanted to clear up that Hakan never said a "four month" partnering process. He said "formal" partnering process - so we really did not get a time frame on this call. They have said earlier this year that it could be before or after resubmission, and Al has said he expects it before the end of the year. He did say four month according to the transcript. Here's an excerpt: Hakan S. Edstrom President and Chief Operating Officer Thank you. As the comparison the date that we are very pleased with the outcome of this trials and we'll now expect - proceed to final as the - new drug application plan submission in the fourth quarter. But let me now briefly adjust the status of partnership efforts for AFREZZA . As we've stated before we have been facilitating the initial diligence efforts of various products over the past several months, while other potential process indicate that there would initiate or resume diligence activity upon data related to our phase III data. Now that the data is available we are kicking up a four month talking process that is intended to announce multiple potential partners to evaluate the AFREZZA opportunity simultaneously. We have engaged companies to run this process and to device with respect to process put forward by potential partners. Our goal is to secure a partner that has the right capabilities, the right approach to diabetes therapy to make AFREZZA the commercial success. We know that it can be. And with those comments, let me turn the call over to Al. Al?
|
|
|
Post by rak5555 on Aug 22, 2013 8:44:35 GMT -5
Too bad the speakers don't proof read the transcript before release. There are so many transcription errors, he could have said either 4 month or formal. Hakan must be really smart because no one can understand him.
|
|
|
Post by brentie on Aug 22, 2013 9:06:10 GMT -5
Too bad the speakers don't proof read the transcript before release. There are so many transcription errors, he could have said either 4 month or formal. Hakan must be really smart because no one can understand him. Rak,that's why I wish the Seeking Alpha transcript would come out. Their transcripts are usually a lot more accurate.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Aug 22, 2013 13:04:29 GMT -5
Too bad the speakers don't proof read the transcript before release. There are so many transcription errors, he could have said either 4 month or formal. Hakan must be really smart because no one can understand him. Rak,that's why I wish the Seeking Alpha transcript would come out. Their transcripts are usually a lot more accurate. Time will tell and if a partnership does not materialize before FDA approval be alarmed if you're a warrant or shareholder. Commercial viability is in question without significant cash flow needed to promote, position and place Afrezza into the marketplace to have a chance as penetration. Afrezza's additional cost over existing insulin treatments is something to make note of as well. To justify Afrezza's added price-tag Afrezza must product differentiate, which is not a simple task and will require an experienced marketing department.
|
|
|
Post by StevieRay on Aug 22, 2013 13:24:46 GMT -5
Rak,that's why I wish the Seeking Alpha transcript would come out. Their transcripts are usually a lot more accurate. Time will tell and if a partnership does not materialize before FDA approval be alarmed if you're a warrant or shareholder. Commercial viability is in question without significant cash flow needed to promote, position and place Afrezza into the marketplace to have a chance as penetration. Afrezza's additional cost over existing insulin treatments is something to make note of as well. To justify Afrezza's added price-tag Afrezza must product differentiate, which is not a simple task and will require an experienced marketing department. The only price target that I've even seen is $2000. If you have any other reference then please post but in the mean time I don't think it fair to say there is a need to justify Afrezza's added price tag. This is very misleading in my opinion.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Aug 22, 2013 13:44:13 GMT -5
Time will tell and if a partnership does not materialize before FDA approval be alarmed if you're a warrant or shareholder. Commercial viability is in question without significant cash flow needed to promote, position and place Afrezza into the marketplace to have a chance as penetration. Afrezza's additional cost over existing insulin treatments is something to make note of as well. To justify Afrezza's added price-tag Afrezza must product differentiate, which is not a simple task and will require an experienced marketing department. The only price target that I've even seen is $2000. If you have any other reference then please post but in the mean time I don't think it fair to say there is a need to justify Afrezza's added price tag. This is very misleading in my opinion. The only price target you've seen is $2000? Interesting. There are many different price assumptions some have even claimed $1,200 per year. You are entitled to your opinion but it's my humble opinion that Afrezza will in fact be priced higher than additional insulin treatments. Due to the mass-manufacturing of needle injected insulin the price correlated with distribution costs have decreased significantly the price of needle injections, which are commonplace and the staple treatment method of diabetics. Also note pens, pumps and pills that are also part of treating diabetes then you have a plethora of various other ways to treat diabetes that directly compete with the demand and need for an inhalable insulin.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Aug 22, 2013 14:39:26 GMT -5
Hi Douge. You are correct in stating that needles are a lot less painful these days. Last night I had dinner with a lady who is T1. I am T2 and on Bydureon which is one shot a week. I asked her about her regiment and she said Metformin and Glucophage. I really couldn't believe she wasn't on insulin so I asked her about it and her response was " I hate needles". Perhaps I am wrong, but I thought all T1's were on insulin. If this lady is that adverse to even the thought of injections, even though they are relatively pain free, I would guess there are many who are of the same mindset. If I am incorrect about all T1's reqyuiring insulin will someone please correct me and offer an explanation how they can get by without it. Thanks, Nada. Welcome Nada, Yes, needles are a lot less painful these days and I'm glad you agree. It's great to hear that you had dinner with a lady. This lady who happened to have T1 and T2 has unfortunately not followed the guidance of her doctor. Often times it is this very lack of self control and discipline that increases and exacerbates diabetes. I recently had lunch with a couple friends who happened to have diabetes, I asked them on their thought about Afrezza. Most were interested but many asked questions concerning the fact that Afrezza entered the lungs. They questioned the safety issues concerning Afrezza's effect on the lungs. While I did tell them that trials have been done and Afrezza clinical patients only had a mild to moderate cough for the first few weeks, they were still rightfully concerned. I agreed Afrezza still has to do long term studies that show Afrezza's effects on the lungs, possibly even after FDA approval but that over 6000 patients have undergone Afrezza treatment. They were still hesitant however and understandably so. One that was a smoker questioned if Afrezza may have an affect on his lungs and I told him how many of the MNKD trial's had inclusion criteria for non-smokers. Another friend asked what would happen if she had a cold and how that may effect how much or how little she inhaled. Another stated how Afrezza was revolutionary and how children may prefer to inhale rather than inject insulin, I agreed but I stated how Mnkd still has yet to run test on children but have been advised by FDA to do so yet have not done so. Then I told them how so many surveys have been done about Afrezza to see how many diabetics would be interested. They agreed and said they could see why; it's because inhalable insulin sounds intriguing but then I mentioned how Pfizer had this same patient and survey feedback from potential customers and patients in the Exubera trials. Unfortunately, few sales were achieved by Pfizer.
|
|
|
Post by goyocafe on Aug 22, 2013 16:26:19 GMT -5
A smoker worried about the affect a drug will have on his lungs is one of the biggest oxymorons I've ever heard.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Aug 22, 2013 16:35:09 GMT -5
A smoker worried about the affect a drug will have on his lungs is one of the biggest oxymorons I've ever heard. Nicotine addiction is a terrible thing and Mnkd will be losing a segment of potential customers if Afrezza addresses a warning for smokers.
|
|