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Post by agedhippie on May 11, 2017 19:33:03 GMT -5
I have said a few times that I don't like the look of Fiasp because I am not sure of the effect of the additions. It will be interesting to see how the insurers take to it. Arguably there is not a huge gain over existing RAA so they may well be slow. Fiasp is launched in Canada, and should be launched this quarter in Europe so this is where we see if doctors view it as the next step in RAA, or just another insulin. Novo Nordisk A/S will have to negotiate the price in Canada and Europe. It is difficult to see an advantage. I suppose if the cost is the same, they will not care. I think it is non inferior.
It is priced the same as Novolog so it gets sold as a better Novolog for the same price. The trial data is only there for non-inferior but in trials (ONSET-2 I think) it returned better results than Novolog. It cannot be used in pumps in Canada currently and that is the subject of the ONSET-5 trials. This illustrates the problem for small companies like Mannkind - the ability to expand the label beyond the Phase 3 trial. There is only two weeks of trial data to support pumps in Canada (it is approved for pumps in Europe)? No problem, spin up a full trial to provide it.
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Post by sayhey24 on May 11, 2017 19:50:01 GMT -5
I understand everything you're saying. For some reason I'm having trouble getting you to understand what I'm saying. I understand that Afrezza is non-inferior due to A1c results. I'm not talking about A1c, I'm talking about speed, just like you. Fiasp has been genetically engineered to get absorbed more quickly through subcutaneous tissue, thus decreasing the time to become bioavailable in the blood. It is faster than current RAAs at doing this, which is why it works more quickly. Afrezza becomes bioavailable in the blood essentially within seconds, whereas Fiasp takes several minutes to cross through sub q tissue to reach a therapeutic level. I'm not arguing that point. I'm not arguing that Fiasp should be in the same class as Afrezza. More or less, I'm saying Fiasp won't get labeled as an RAA, which would leave it with only one option (ultra rapid) because I also don't think the FDA will create a class just for Afrezza, since that's essentially what they'd be doing if they deny Fiasp ultra rapid status. I would argue (as you are) that Fiasp is more similar to RAA than it is to Afrezza. However, I think it is different enough from RAA's that it should not be labeled with the RAAs. As I've been saying since my initial post, it matters what metric they use to determine speed. Does area under the curve matter (Afrezza's first phase vs Fiasp's vs RAAs)? Does onset of action matter? Does time to peak concentration matter? What metric are they going to use to determine "ultra rapid?" On top of that, what time frame will they allow for ultra rapid? If you look at the TABLE, you'll see that several onset of actions as well as time to peak concentrations exist within the same class. There is a spectrum. How will the FDA handle that? Where is their cutoff for ultra rapid vs rapid acting? Europe has already decided that it met their cutoff for ultra rapid, which is the basis for why I believe the FDA will as well. The FDA has a mind of its own and doesn't have to follow anyone else, but you also have to consider that with the political power a company like NOVO has, they're not going to invest the money it takes to create a drug just to have it placed into the same class as the one it's replacing, especially if they already got recognized as being different by another large regulatory body. NOVO is going to flex all their muscles to ensure Fiasp becomes Ultra rapid. It all depends on the parameters the FDA decides to use to structure the ultra-rapid class. We'll probably get our answer by the end of the year. I understand exactly what you are saying. What I am saying is it still is not fast when compared to a healthy pancreas or afrezza which profiles exactly like a healthy pancreas because they are both using monomer human insulin. Look at the Fiasp/Novolog profiles. Fiasp is 15 minutes faster but it has the same humpback profile as Novalog. You need that sharp peak monomer human insulni provides to "punch" the liver. If afrezza is approved as "ultra" your question on "it matters what metric they use to determine speed" has been determined - Fiasp will need to perform the EXACT same clamp studies afrezza did against Novalog. You can argue that Fiasp should be in the same class as Afrezza but what I am telling you based on the science is Fiasp can not show non-inferiority to afrezza in the clamp studies. Thats just the way it is. If Fiasp was first it would get the designation but it will be second and it will NOT show NON-INFERIORITY. I also am telling you, this was not suppose to happen. MNKD was suppose to be bankrupt by now. Instead they have obsoleted every T2 treatment, especially metformin and they have obsoleted all current and in-works RAA like Fiasp. And my God, Amgen just opened their Dubia office, someone will get China soon and MNKD is actually going to make it. This was not Pfizers, Ely Lilly's, Bristol Meyers, Mercks or Nova Nordisk plan. MNKD was suppose to go bankrupt and Fiasp would slide right in. If the FDA designates Fiasp as ultra after showing inferiority to afrezza, the FDA would be looking at a major lawsuit. With Bernie Sanders already running around about insulin price fixing I am pretty sure the FDA will play by the rules on this one.
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Post by kuka on May 11, 2017 20:12:54 GMT -5
The Middle Eastern Country comment confirmed the shipment rumors and is THE reason for the Volume and Price Rise in the last 5 days....PERIOD.
This will go up until we get confirmation
Suggest Longs Keep Buying until you cant pay your light bills
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Post by silentknight on May 12, 2017 1:40:19 GMT -5
The Middle Eastern Country comment confirmed the shipment rumors and is THE reason for the Volume and Price Rise in the last 5 days....PERIOD. This will go up until we get confirmation Suggest Longs Keep Buying until you cant pay your light bills Except for today of course, when we were down 20%. That of course doesn't count. Longs buying until they cant pay their light bills is exactly what led to people being underwater more than 95% in their original innvestments. I won't be buying anymore until there's signs of life. But thanks for the tip...
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Post by username on May 12, 2017 8:24:49 GMT -5
What if the FDA delays approving the label change until after Fiaso is approved, and then defines the "ultra fast" category in such away as to include both Afrezza and Fiasp?
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Post by buyitonsale on May 12, 2017 9:05:25 GMT -5
I have added to my position yesterday and today. Looking forward to international expansion news.
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Post by MnkdWASmyRtrmntPlan on May 12, 2017 11:36:23 GMT -5
Yes, buyit, it will be interesting to see if MNKD can sell Afrezza in another country where they don't have such forces working against them. Of course, they have no sales experience there, which, of course, is why we need Amgen.
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Post by babaoriley on May 12, 2017 12:07:50 GMT -5
I have added to my position yesterday and today. Looking forward to international expansion news. That news was initially leaked, obviously, then confirmed by Matt on the call. Now, the question is, what details of the deal were leaked? Hopefully, hardly any details were leaked (as the share price has stalled), and we can hope for an upside surprise. You remember upside surprises, right? We had one on the day of the Advisory Committee meeting, just about a financial lifetime ago. Hey, and our FDA approval came earlier than expected, another upside surprise!
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Post by kc on May 12, 2017 12:18:09 GMT -5
Let's hope they address this at the shareholders meeting. We need a happy moment to have a victory somewhere. They would hold the news at this time for the meeting if they have news.
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Post by orlon on May 12, 2017 13:00:58 GMT -5
I've learned over the years not to get my hopes up or believe anything this management says until it is engrave in stone and supported by facts. With that in mind I suspect we will be below $1.00/sh going into the ASM. I personally voted NO on all items.
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Post by tchalaa on May 12, 2017 13:40:47 GMT -5
Let's hope they address this at the shareholders meeting. We need a happy moment to have a victory somewhere. They would hold the news at this time for the meeting if they have news. For how many years have we been chasing the carrot? we keep on jumping from one binary event to the others. My question is: why is mannkind having all these difficulties to increase sales with more than 100 sales reps on the field since February 2017 ? Now all over the place is Middle East, what would have happen if we never had that embarrassing rumor since we are once again cadged in this binary event. From $110 (22*5) to $1.1 (0.22*5) let you scratch your head while asking yourself what is the reality behind all the collaborations, memorandums and agreements: RLS, VDEX, One Drop and unconventional relation with Amgen after the FLOP with Sanofi We need sales et urgently - shareholders accepted dilution, reverse split, dilution but also ask for some SALES and REAL DEALS
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Post by kc on May 12, 2017 14:48:40 GMT -5
Tchalaa, its a bad dream. I don't know aobut (22 X 5) But I know many who were (10 X 5). I myself sold a lot at the (10 X 5) for a tax loss last year. Now my avg is very low around the (3 X 5) range. But foolishly I keep buying shares (my MannKind addiction) I need a 12 step program.
I can't believe this is the end for MannKind. . Hopefully its the new beginning. Maybe they have a deal in the Middle East. I hope they announce it next week. There is some reason that 64,925,600 share traded Monday - Thursday. Somebody knows something. It can't be just the HFT shorts grinding up the sausage over and over again.
I thought the Conf Call was very guarded. They didn't take any analyst calls. I thought that was very odd. Perhaps they were careful not to get a call where they had to disclose too much. But there is a fire burning and I hope its a positive one for all of us. As the market gets ready to close today I see we have 5,310,000 share traded so far today and 64,925,600 shares Monday - Thursday.
How many outstanding shares are there? 100,000,000 shares.
What's up with that?
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Post by cretin11 on May 12, 2017 15:13:54 GMT -5
Tchalaa, its a bad dream. I don't know aobut (22 X 5) But I know many who were (10 X 5). I myself sold a lot at the (10 X 5) for a tax loss last year. Now my avg is very low around the (3 X 5) range. But foolishly I keep buying shares (my MannKind addiction) I need a 12 step program.
I can't believe this is the end for MannKind. . Hopefully its the new beginning. Maybe they have a deal in the Middle East. I hope they announce it next week. There is some reason that 64,925,600 share traded Monday - Thursday. Somebody knows something. It can't be just the HFT shorts grinding up the sausage over and over again.
I thought the Conf Call was very guarded. They didn't take any analyst calls. I thought that was very odd. Perhaps they were careful not to get a call where they had to disclose too much. But there is a fire burning and I hope its a positive one for all of us. As the market gets ready to close today I see we have 5,310,000 share traded so far today and 64,925,600 shares Monday - Thursday.
How many outstanding shares are there? 100,000,000 shares.
What's up with that? Curious about your comment that it can't be just the HFT shorts grinding up the sausage again and again. Why can't it be, and in fact isn't that the most likely thing (based on the past few years of what we've experienced)? As for no analyst calls yesterday, i don't think they've taken any during the past several calls, so that seemed par for the course lately.
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Post by mytakeonit on May 12, 2017 15:20:28 GMT -5
It's called churning and burning ... well I called it that when I was a day trader. You have shorts, day traders, and even brokerage houses doing it.
All you have to do is make $250/day and you make a decent living. Multiply that many times over ... and you're a day trader.
I just realized later that it was a lot of work, especially at tax time, and found that I could make even more buying great stock and sitting on it. ?? Warren Buffett strategy?
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Post by saxcmann on May 12, 2017 16:37:31 GMT -5
Tchalaa, its a bad dream. I don't know aobut (22 X 5) But I know many who were (10 X 5). I myself sold a lot at the (10 X 5) for a tax loss last year. Now my avg is very low around the (3 X 5) range. But foolishly I keep buying shares (my MannKind addiction) I need a 12 step program.
I can't believe this is the end for MannKind. . Hopefully its the new beginning. Maybe they have a deal in the Middle East. I hope they announce it next week. There is some reason that 64,925,600 share traded Monday - Thursday. Somebody knows something. It can't be just the HFT shorts grinding up the sausage over and over again.
I thought the Conf Call was very guarded. They didn't take any analyst calls. I thought that was very odd. Perhaps they were careful not to get a call where they had to disclose too much. But there is a fire burning and I hope its a positive one for all of us. As the market gets ready to close today I see we have 5,310,000 share traded so far today and 64,925,600 shares Monday - Thursday.
How many outstanding shares are there? 100,000,000 shares.
What's up with that? Right kc...70 million shares traded and no real big news. Hmmm?
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