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Post by dreamboatcruise on Feb 27, 2015 13:33:25 GMT -5
The portion about out of cycle visits I think is quite valid. I have some issues with another part of the article.
The survey of patients, though small, is interesting. 9% had heard of Afrezza. Unfortunately, though perhaps expected, a vast majority are not going to fight to go against doctors recommendation. One flaw I see in this article is that it sets up a scenario that is perhaps totally hypothetical. Where do we get a doctor that recommends waiting "1 year" to see if there are side effects. Were any doctors surveyed to see if many hold this view? One year seems like a strange period. The trials for Afrezza were extensive. The modest loss in lung function reversible on stopping Afrezza. What concern does this hypothetical doctor have that will disappear within a year. If it is the probably unfounded fear that insulin actually causes lung cells to become cancerous, is that worry going away after just one year? If there is real evidence that significant number of doctors would actively recommend against Afrezza because of safety concerns, I think it too optimistic to think they are going to be satisfied with just an extra year of patient results. But still, I question the validity of this doctor resistance on safety concerns as being a significant factor in slow early script rates.
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Post by babaoriley on Feb 27, 2015 13:38:04 GMT -5
Huge market, dbc, enough will try it to give us a successful launch, but that's not going to be evident overnight.
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Post by cubonwallstreet on Feb 27, 2015 13:51:30 GMT -5
The long, extensive process Afrezza had to go through before being FDA approved should (key word) help; however, it will likely go unnoticed by many medical professionals in regards to safety.
Many doctors are tired, over-worked, and want to avoid any (unnecessary)change(s) that could negatively impact their practice. Per CC, they are marketing toward the medical professionals first-- which is prudent-- but I think we end up seeing the most benefit from DTC adverts and increasing patient demand.
I know it is wise to educate medical professionals prior to DTC adverts, but do you think SNY/MNKD has Afrezza's label in mind with their timing of the DTC push? Is it possible they will have an improved label before beginning DTC? This would be a huge plus, if so.
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Post by babaoriley on Feb 27, 2015 14:00:19 GMT -5
Some folk here know what an improved label involves, time wise and work wise, perhaps they can chime in. I would think to get an approved label, further trials must be done, and results analyzed and submitted to the FDA, so I think it's a fairly long process - 12-18 months would be my guess. Would love to know that my estimate is far too long.
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Post by savzak on Feb 27, 2015 14:11:53 GMT -5
The I think we end up seeing the most benefit from DTC adverts and increasing patient demand. I agree. Though it is essential that the docs get informed, I suspect the SNY reps will carry the ball just so far. The bigger motivator for the docs to become informed will be consumers.
The question is, in what group is the demand likely to initiate; the docs, or the patients? To some degree it will be both but I suspect the larger portion of the early demand will initiate in consumers. I think the cycle of feedback and information will create a paradigm something like this:
1. SNY reps succeed to some extent in informing docs who willingly prescribe Afrezza. 2. Social media buzz continues engendering new interest among diabetics who haven't heard of Afrezza. 3. Satisfied patients create more social media buzz and provide feedback to their docs who become more convinced that Afrezza really is what the SNY reps made it out to be. 4. The healthcare networking buzz starts up and those less inclined initially to prescribe Afrezza get interested and figure it's time they get a bit more serious about getting informed. 5. The cycle of interest/information/demand continues.
At the end of the day, whether the initial demand comes mainly from docs becoming believers after being impressed by SNY reps or from consumers really may not matter. It reminds me of building a fire. It's very difficult to get a blazing fire without a little time, regardless of how dry your kindling is and how many matches you have. But if you've got good materials, it really doesn't matter whether you start the fire on the right or on the left or in the back or in the front. With a little time, you end up with a blaze.
We all see that the ingredients for a good blaze with Afrezza are here. We have a wonderful product that we know to be better than its competition. We seem to have good pricing and very competent marketing. With the weekly script information we see small flames. With the social media buzz we see those flames being fanned. Plenty of dry kindling, plenty of oxygen, plenty of matches. A few small embers forming. It's just a matter of time.
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Post by cubonwallstreet on Feb 27, 2015 14:17:11 GMT -5
The I think we end up seeing the most benefit from DTC adverts and increasing patient demand.
At the end of the day, whether the initial demand comes mainly from docs becoming believers after being impressed by SNY reps or from consumers really may not matter. It reminds me of building a fire. It's very difficult to get a blazing fire without a little time, regardless of how dry your kindling is and how many matches you have. But if you've got good materials, it really doesn't matter whether you start the fire on the right or on the left or in the back or in the front. With a little time, you end up with a blaze.
Great analogy. |
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Post by cubonwallstreet on Feb 27, 2015 14:21:04 GMT -5
Some folk here know what an improved label involves, time wise and work wise, perhaps they can chime in. I would think to get an approved label, further trials must be done, and results analyzed and submitted to the FDA, so I think it's a fairly long process - 12-18 months would be my guess. Would love to know that my estimate is far too long. Hoping your estimate is far too long as well and/or they began this process months ago. Would it be public knowledge if they were pursuing an approved label? |
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Post by Deleted on Feb 27, 2015 15:01:29 GMT -5
As I mentioned eons ago (it feels), the short tactic will be to start casting stones at valuation, saying that hundreds of millions in sales are already baked in....But I must admit, I was way wrong, because I'm obviously unable to do math, as folks like Ken and PA are telling me that BILLIONS are currently baked into the price.
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Post by dreamboatcruise on Feb 27, 2015 15:02:51 GMT -5
It seems like the social media buzz is primarily among T1s (and maybe by extension applicable to T2s already on prandial)... and it seems compelling. With regard to that big part of the target audience that is composed of T2s whose doctors know they should be on insulin, but the patient is resisting... I'm skeptical as to whether social media or even DTC advertising really compels them. It may be a much easier sell by the doctor to convince these patients to go on Afrezza vs a injectable, but I suspect it would still require the doctor doing the pushing. Even Afrezza is altering their daily routine and requires a patient to basically admit to themselves that they are past the point of hoping to control the disease with diet and lifestyle alone.
I guess I'm hoping that it doesn't take a label change, or another year of proven safety, to convince most, if not all, doctors to significantly push Afrezza among this large pool of patients that should be on insulin but aren't.
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Post by cubonwallstreet on Feb 27, 2015 15:07:52 GMT -5
It is always interesting, to me, how authors like Ken and PA from Seeking Alpha make these determinations; yet, they remain "long" the stock and feel the need to churn out articles week after week.
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Post by dreamboatcruise on Feb 27, 2015 15:09:54 GMT -5
As I mentioned eons ago (it feels), the short tactic will be to start casting stones at valuation, saying that hundreds of millions in sales are already baked in....But I must admit, I was way wrong, because I'm obviously unable to do math, as folks like Ken and PA are telling me that BILLIONS are currently baked into the price. Yeah, that comment made no sense to me unless one totally rejects Mannkind's comment that the deal is equiv to 25% royalty. The company is indicating they are taking fiscally conservative approach to pipeline development, with the milestone payments presumably more than covering it. Given that manufacturing is already paid for at cost, the equiv 25% royalty should all appear on the bottom line. Does anyone recall where he has explained his math to make that assertion? Is it assuming some low billions of sales and that we don't get there for quite some years and thus applying a discount factor... or what? |
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Post by babaoriley on Feb 27, 2015 16:07:28 GMT -5
It seems like the social media buzz is primarily among T1s (and maybe by extension applicable to T2s already on prandial)... and it seems compelling. With regard to that big part of the target audience that is composed of T2s whose doctors know they should be on insulin, but the patient is resisting... I'm skeptical as to whether social media or even DTC advertising really compels them. It may be a much easier sell by the doctor to convince these patients to go on Afrezza vs a injectable, but I suspect it would still require the doctor doing the pushing. Even Afrezza is altering their daily routine and requires a patient to basically admit to themselves that they are past the point of hoping to control the disease with diet and lifestyle alone. I guess I'm hoping that it doesn't take a label change, or another year of proven safety, to convince most, if not all, doctors to significantly push Afrezza among this large pool of patients that should be on insulin but aren't. dbc, even if just those that are needle adverse make up the vast majority of the patients we get initially, the word of mouth based on their experience will convince some of those that currently need a doctor to push them to finally try it. But that's fine, we can't manufacture enough of this stuff yet anyway. |
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Post by beardawg on Feb 27, 2015 16:13:46 GMT -5
As I mentioned eons ago (it feels), the short tactic will be to start casting stones at valuation, saying that hundreds of millions in sales are already baked in....But I must admit, I was way wrong, because I'm obviously unable to do math, as folks like Ken and PA are telling me that BILLIONS are currently baked into the price. Yeah, that comment made no sense to me unless one totally rejects Mannkind's comment that the deal is equiv to 25% royalty. The company is indicating they are taking fiscally conservative approach to pipeline development, with the milestone payments presumably more than covering it. Given that manufacturing is already paid for at cost, the equiv 25% royalty should all appear on the bottom line. Does anyone recall where he has explained his math to make that assertion? Is it assuming some low billions of sales and that we don't get there for quite some years and thus applying a discount factor... or what? I believe he used a very small multiple like 2.8 or something on $3 billion in sales. His reasoning was that it should be the same as other biotechs. Of course he selectively chose ones to point out that fit his agenda - and even halved it from theirs. It's in the comments I believe. |
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Post by 1 percenter on Feb 27, 2015 16:20:38 GMT -5
Yeah, that comment made no sense to me unless one totally rejects Mannkind's comment that the deal is equiv to 25% royalty. The company is indicating they are taking fiscally conservative approach to pipeline development, with the milestone payments presumably more than covering it. Given that manufacturing is already paid for at cost, the equiv 25% royalty should all appear on the bottom line. Does anyone recall where he has explained his math to make that assertion? Is it assuming some low billions of sales and that we don't get there for quite some years and thus applying a discount factor... or what? I believe he used a very small multiple like 2.8 or something on $3 billion in sales. His reasoning was that it should be the same as other biotechs. Of course he selectively chose ones to point out that fit his agenda - and even halved it from theirs. It's in the comments I believe. Ken used two established BIG PHARMAS, not biotechs as examples. Ken is a disingenuous putz. |
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Post by beardawg on Feb 27, 2015 16:46:06 GMT -5
The biggest no-no on the question was that it was a leading question. It assumed that doctors would be concerned about the safety of Afrezza. OF COURSE people would be more likely to follow the doctor's recommendation if they've never heard of the drug and the doctor simply tells them he wants to give it time to test the safety. Who wouldn't, when you put it that way? As many drugs as doctors prescribe that have side effects, if they say they are concerned, it must mean it is serious. So the very words of the question puts in mind that the drug has serious side effects, from the start, and will cause the questionee to already have a negative view of it. They might as well had asked, "would you take an inhaled insulin drug that could possibly kill you or wait until the side effects are known like your doctor suggests?"
This has nothing to do with what will happen in the real world. Doctors wouldn't even bring it up if they were worried about safety. They would simply wait. I don't think too many will be worried about safety after talking to Sanofi.
I think he deliberately chose that form of question to get the results he wanted.
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