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Post by brentie on Sept 8, 2014 10:41:47 GMT -5
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Post by Deleted on Sept 8, 2014 11:02:49 GMT -5
From YHOO
Afrezza to be launched at same time as Tojeo.
Tojeo can claim lower hypo.
Clever device is the advantage for Afrezza.
Not a huge ramp up. "Controlled launch."
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Post by jpg on Sept 8, 2014 11:15:36 GMT -5
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Post by dreamboatcruise on Sept 8, 2014 11:28:05 GMT -5
If you could post a link that would be appreciated. Didn't find this on Yahoo Finance for either company.
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Post by Deleted on Sept 8, 2014 11:32:07 GMT -5
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Post by rch51 on Sept 8, 2014 12:10:53 GMT -5
What is a "controlled launch" This needs to be explained a little better I think. Maybe I'm reading this wrong but to me dipping their toes into the water isn't exactly what I was expecting of Sanofi. Why must Afrezza be tied to Tojeo? It's a marvelous stand alone product. Something smells here.
I hope we get some clarification tomorrow from MNKD.
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Post by daduke38 on Sept 8, 2014 12:12:35 GMT -5
A copy of my post from the other board about SNY's comments: They stated that they are going to lauch in Jan. with Toujeo. The only problem is Toujeo just submitted there NDA in July for Toujeo and have stated they are looking at a mid 2015 launch for Toujeo. And that is if it gets approved. I hope someone can prove me wrong, but it seems to me that SNY may have snaked us on this deal. And why aren't they marketing "A" as a seperate treatment? They talked like "A" was an easier way to deliver, but said nothing about the benefits or the marketing of "A" to pre diabetics. Listen to the conference call and it really sounds like "A' isn't a big deal for SNY.
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Post by goyocafe on Sept 8, 2014 12:21:32 GMT -5
A copy of my post from the other board about SNY's comments: They stated that they are going to lauch in Jan. with Toujeo. The only problem is Toujeo just submitted there NDA in July for Toujeo and have stated they are looking at a mid 2015 launch for Toujeo. And that is if it gets approved. I hope someone can prove me wrong, but it seems to me that SNY may have snaked us on this deal. And why aren't they marketing "A" as a seperate treatment? They talked like "A" was an easier way to deliver, but said nothing about the benefits or the marketing of "A" to pre diabetics. Listen to the conference call and it really sounds like "A' isn't a big deal for SNY. I gave you thumbs up! Hope it makes you feel a little better. Never mind votes on "the other board"; I can't imagine the range of members' mind sets there.
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Post by babaoriley on Sept 8, 2014 12:22:09 GMT -5
As Dirty Harry would say, "Marvelous."
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Post by mannmade on Sept 8, 2014 12:42:42 GMT -5
Here's my take (imho) as follows:
1.) Controlled launch could be code for do not see having enough supply at launch
2.) Stating "Clever Device" is an advantage for Afrezza, I am hoping is an intentional red herring to throw off the competition as I cannot imagine the science staff at Sanofi would recommend purchase just for this reason as insulin pens are currently sufficient and offer some parity in this matter of delivery pain free etc...
3.) Launching with U300, while I see the benefits to this strategy for Sanofi, I also think (am hoping it is a red herring) as we all know Afrezza is suited for all Basal combos and thus offers a much larger potential revenue stream to Sanofi. And surely they must realize this.
Trying to make sense of above is mostly guesswork but inside Sanofi the hand off from science team to marketing/brand team(s) is taking place and so am hoping my guesses are correct as they would seem consistent with the shroud of secrecy that Sanofi has said would surround their marketing plans moving forward post announcement. The judges will at the end be the finance team... So now all three must learn to play together at Sanofi...
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Post by daduke38 on Sept 8, 2014 12:55:32 GMT -5
A copy of my post from the other board about SNY's comments: They stated that they are going to lauch in Jan. with Toujeo. The only problem is Toujeo just submitted there NDA in July for Toujeo and have stated they are looking at a mid 2015 launch for Toujeo. And that is if it gets approved. I hope someone can prove me wrong, but it seems to me that SNY may have snaked us on this deal. And why aren't they marketing "A" as a seperate treatment? They talked like "A" was an easier way to deliver, but said nothing about the benefits or the marketing of "A" to pre diabetics. Listen to the conference call and it really sounds like "A' isn't a big deal for SNY. I gave you thumbs up! Hope it makes you feel a little better. Never mind votes on "the other board"; I can't imagine the range of members' mind sets there. Thanks for the thumbs up, but that wasn't my concern. It's thumbs down without a response. And SNY was very specific about launching it with Toujeo. Hopefully, it is Corporate games as I don't buy the remarks weren't made by the Marketing Dept. All they had to say, was that is a question for marketing who are not present. I did find the sale of the Valencia land interesting, though. Maybe this does end up being a buyout.
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Post by derek2 on Sept 8, 2014 13:57:40 GMT -5
If you could post a link that would be appreciated. Didn't find this on Yahoo Finance for either company. That was my posting on YMB. So I guess the link would be www dot dereksaidsomething dot com Most important is the statement regarding launch timing and regarding intensity of launch. Dr. Elias Zerhouni Head of Global Research & Development Sanofi A reference to rolling out Afrezza & Toujeo as a prandial / basal pair. Then talks about Toujeo being the drug that will give the differentiation, based on its profile and hypo advantage. I've cut some stuff out for brevity, but I don't think I'm distorting anything by doing so. Here's the thing: Toujeo was accepted for review in early July. A standard 10-month review (no indication it would be anything else - it isn't a breakthrough drug) would put PDUFA in late April or early May. Add 6 months (typical) rollout (package design, insert design & printing, sales force training, inventory manufacturing) and you get Oct / Nov 2015. So there's a disconnect here. MNKD says Q1 2015, Mr Zerhouni says early 2015, but Toujeo won't launch until late 2015 IF it's approved. Q1 != Q4 I would expect that MNKD will clarify this on Tuesday.
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Post by dreamboatcruise on Sept 8, 2014 14:14:44 GMT -5
So I guess the link would be www dot dereksaidsomething dot com Derek... your site seems to be down... admit it, that can mean only one thing... you're being bought out.
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Post by derek2 on Sept 8, 2014 14:26:17 GMT -5
So I guess the link would be www dot dereksaidsomething dot com Derek... your site seems to be down... admit it, that can mean only one thing... you're being bought out. Actually, it would have been funny if it was some weird web site. Hopefully we'll breathe a sigh of relief tomorrow regarding rollout schedule.
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Post by ashiwi on Sept 8, 2014 14:34:36 GMT -5
What if there is a delay or rejection by the FDA of Toujeo? Will Afrezza launch have to wait?
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