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Post by kc on Sept 27, 2014 8:40:07 GMT -5
I read somewhere that India tends to try to make copycat products of legitimate drugs. How do they prevent that with a drug that has a solid patent in the rest of the world?
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Post by mannmade on Sept 27, 2014 9:43:03 GMT -5
I read somewhere that India tends to try to make copycat products of legitimate drugs. How do they prevent that with a drug that has a solid patent in the rest of the world? India and China are the two biggest offenders in this area. However it seems two things will be a factor with Afrezza regarding this conversation: 1.) Sanofi is Global and has a working relationship in China, hopefully taking care of one of the two biggest offenders 2.) Perhaps more importantly the process in combining Insulin with Technosphere is apparently so complicated that it may make the effort so difficult and expensive that it is not worth the effort. (Comments welcome as I have no factual data to back this up, only conversations I remember reading in the past on the same subject.)
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Post by kc on Sept 27, 2014 9:51:57 GMT -5
China is an interesting country. They have multiple Sanofi insulin production locations there. so hopefully there is enough trust that they could produce safely there for distribution to the Chinese market. perhaps the approval process is easier in China too?
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Post by daduke38 on Sept 27, 2014 10:15:42 GMT -5
Controlled launch, but the pre-diabetic market has huge potential and patient results may confirm what Al said in his interview, which can lead to label improvement as well. Don't forget EU either, not as far away as some think. Finally, there is a real possibility that Pierre is laying a smokescreen for competitive reasons. If physician demand indicates more than prescribing for pre-D's Sanofi will adjust to demand. I've been wondering about the EU submission...I don't believe it's been filed yet and I would expect around a 6 month wait after submission before approval. Plus doesn't SNY have to then go to each country to negotiate pricing? (I thought I read that somewhere). We might see a country like India approving Afrezza before the EU (India usually will follow the FDA's rulings). Check out PSDV who just got FDA approval yesterday. They have had EU approval for some time, but I think are only licenced in 2 countries. They recently broke down talks with France as they could not come to pricing terms. Now they are a small specialized Pharma and I am sure SNY has been through the loop many times, so it should go quicker. I agree that we could be in India sooner. Which brings up a thought, Wonder how soon Isreal will be?
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Post by BlueCat on Sept 27, 2014 10:31:47 GMT -5
Or China?
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Post by Deleted on Sept 29, 2014 11:43:28 GMT -5
"Pierre Chancel, a senior vice president of Sanofi's diabetes unit, said he does not expect Afrezza to compete with its existing products. Instead, it will be marketed to those patients who are struggling to start insulin because they don't like injections, he said. "It's going to be a nice complement and upgrade to our portfolio," Chancel told analysts in a conference call. Just pulled this from another board. It is a quote from the day the deal was announced. Sometimes it's easy to get caught up in the moment, but if this is SNY's maketing plan, it doesn't bode well for sales. What am I missing? And how was that missed? My mother (and many other mothers, I'm sure) used to say: "Any job worth doing is worth doing well" "If you want a job done well, do it yourself"
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Post by thekindaguyiyam on Sept 29, 2014 14:49:49 GMT -5
Thanks for all the thoughts and replies! Really helped. I have a tendency to over analyze at times. Sometimes not a good trait, but sometimes it can be. Let's not forget that he doesn't want to give the impression that afrezza is going to cannibalize it's other meds (even if it does).
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Post by BlueCat on Sept 29, 2014 15:00:24 GMT -5
Thanks for all the thoughts and replies! Really helped. I have a tendency to over analyze at times. Sometimes not a good trait, but sometimes it can be. Eh. IMHO "over" is truly "over-used". And generally by those that find thinking painful. 'over analyze' 'over think' 'over sensitive' and so on. Sometimes gotta know what something isn't, to know best what it is. Keep up the good work
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Post by mnholdem on Sept 29, 2014 16:53:13 GMT -5
This could be a cleverly deceptive marketing plan. By introducing Afrezza as an effective treatment for pre-diabetics, Sanofi would face much less competitive pressure. The PB market is dominated by oral medication and it can be easily demonstrated that Afrezza is far superior to pills. By taking this approach, PCP's and endos will see first hand how convenient Afrezza is, for both the needle-leary patient AND the busy doctor, and they will quickly recognize it as being well-suited for other diabetic patients.
Clever, because Sanofi would first expand the market via millions of pre-diabetics becoming patients, then quickly win over physicians who begin prescribing it to their T2 & T1 patients. Sanofi would not have to start by attempting to convince physicians to replace current (and familiar) fast-acting RAA's... they'll figure it out for themselves. Brilliant!
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Post by jpg on Sept 29, 2014 20:18:01 GMT -5
Avogadro,
I''m not certain why you bring this up again as the previous page covered the topic rather well. I guess you are playing on insecurities of investors who don't grasp the nuances of the diabetic market or are just generally speaking nervous at what might go wrong. You add little new except for an irrelevant high school saying.
As for those who still doubt Sanofi means what it says it will do I for one certainly hope you are wrong and that Sanofi will do as it says.
What I hope Sanofi will do is exactly as Sanofi said it will do: first sell Afrezza to patients who should be on insulin but aren't on insulin because of fear of needles. No more then that. It is way way enough. The market is 10 times bigger then any injectable prandial market for type 2 ever will be.
Again I don't see what is bad or ominous about this. It's a great and huge market with little to no competition. I think Avogadro is simply running out of original ideas?
JPG
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Post by daduke38 on Sept 29, 2014 20:33:05 GMT -5
Thanks for all the thoughts and replies! Really helped. I have a tendency to over analyze at times. Sometimes not a good trait, but sometimes it can be. Eh. IMHO "over" is truly "over-used". And generally by those that find thinking painful. 'over analyze' 'over think' 'over sensitive' and so on. Sometimes gotta know what something isn't, to know best what it is. Keep up the good work Pretty profound! "Sometimes gotta know what something isn't, to know best what it is." I like that. But I wouldn't say thinking is painful, more tiresome. I'm a vey simple man that knows my short comings. And I also like to show appreciation for civil replies to a post that wasn't thought out before putting it up! And "over" is over used. Good post!
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Post by obamayoumama on Sept 29, 2014 20:52:13 GMT -5
They have to do a controlled launch. They will only have 3 lines of production to start. I would guess that when MNKD gets the milestone payment in November for the certification of the three lines they will be ordering more equipment. The bottleneck and reason for the controlled launch is the lack of production capacity.
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Post by babaoriley on Sept 29, 2014 21:37:38 GMT -5
Control away, that's fine, but launch it in the first quarter, pleeeeease!
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Post by mannmade on Sept 30, 2014 0:00:55 GMT -5
IMHO, just way too much speculation here... You have to believe they know what they are doing and that Al is still the guy who is in charge of making sure that the deal was the right one for what they are doing... Sanofi is a great company and they certainly have the sales force.
I for one have contacted my doctor and asked her to get me the phone number of her Sanofi rep so i can ask some questions about the marketing of Afrezza.... But until we have some facts, it is all just guessing and I for one prefer to deal with more concrete information... So I fall back on the science and the deal itself, as I prefer not to speculate on how serious Sanofi is about taking Afrezza to market until such time as I have facts that say otherwise... To me so far the facts suggest that they are doing all the right things...
I think anyone who has doubts at this point should make a decision about whether they belong in this particular investment. Don't want to sound too harsh here... but honestly, the doubt is what has allowed the shorts to take down an otherwise brilliant company whose product is on the verge of changing the paradigm for treating diabetes and may even allow for stoping the progression of the disease if the FG can be lowered with less fear of Hypo's resulting from use of Afrezza. And this as I have said before, short of a cure, is the Holy Grail for diabetics. Most of the doubt has now been removed and with it the risk, so now it is just a waiting game... Remember the Science!
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Post by gamblerjag on Sept 30, 2014 1:22:16 GMT -5
Agree Mannmade... How do you vote against Al.. Matt's new upbeat presentations and Pierre's obvious excitement and interjections at the conference.
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