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Post by papihoyos on Sept 8, 2014 14:36:44 GMT -5
I don't trust the french
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Post by dreamboatcruise on Sept 8, 2014 14:59:46 GMT -5
What if there is a delay or rejection by the FDA of Toujeo? Will Afrezza launch have to wait? I cannot imagine that the agreement would allow SNY to indefinitely sit on rights to Afrezza if it is not being marketed. I would rate the chance of Al agreeing to that as asymptotically approaching zero. |
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Post by dreamboatcruise on Sept 8, 2014 15:01:32 GMT -5
The French say Pfff and shrug their shoulders at you  |
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Post by brentie on Sept 8, 2014 15:07:27 GMT -5
Here's my take (imho) as follows: 1.) Controlled launch could be code for do not see having enough supply at launch Here's what he said on that subject... "I don't see it as a huge ramp up because something that people don't always appreciate is that even though it's insulin you still have to produce it, scale up, and make it with the devices. Those steps have to be carefully managed, it's the same for biosimilars, you can announce a biosimilar but to produce it in the quantity that you need is not something you can do overnight. So controlled launch is what we want and then expand." |
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Post by mnholdem on Sept 8, 2014 15:18:28 GMT -5
Tying Afrezza launch to Toujeo doesn't make sense. I think Sanofi is simply not willing to show all their cards yet. Comparing the launch to a bio similar does make sense since Toujeo will be replacing Lantus.
First, I'm wondering if is possible for Toujeo to be approved much earlier than expected.
Second, is production the issue here? Lantus is #1 after all.
EU testing for EMA centralized authorization of Afrezza has been going on for some time now. If Sanofi submits the application this month, EMA has 210 days to authorize, putting EU launch in Spring 2015.
That would increase demand. Perhaps production is the concern. Did Sanofi specifically use the words "Afrezza launch" will occur with Toujeo launch?
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Post by daduke38 on Sept 8, 2014 20:06:38 GMT -5
Tying Afrezza launch to Toujeo doesn't make sense. I think Sanofi is simply not willing to show all their cards yet. Comparing the launch to a bio similar does make sense since Toujeo will be replacing Lantus. First, I'm wondering if is possible for Toujeo to be approved much earlier than expected. Second, is production the issue here? Lantus is #1 after all. EU testing for EMA centralized authorization of Afrezza has been going on for some time now. If Sanofi submits the application this month, EMA has 210 days to authorize, putting EU launch in Spring 2015. That would increase demand. Perhaps production is the concern. Did Sanofi specifically use the words "Afrezza launch" will occur with Toujeo launch? Yes they did, but said in early 2015. "A" is only approved in USA as you well know. Toujeo won't be approved (assuming it is) until late spring early summer in the USA. Which would push the launch of the 2 combined back to maybe 2016. I am just going by what the man from SNY said. I've seened this spun about 20 different ways today, and hopefully MNKD will clear this up tomorrow. |
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Post by alcc on Sept 8, 2014 22:31:40 GMT -5
This is deeply troubling. On the original conf call announcing the partnership I heard the French guy say he sees Afrezza as giving DM patients another alternative because of the inhaler. Al had to jump and add that Afrezza's advantage is more than the inhaler. The guy's flippant comment bothered me at the time, but I waved it off as mere misspeak. And now this.
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Sanofi CC
Sept 8, 2014 22:44:28 GMT -5
via mobile
Post by bradleysbest on Sept 8, 2014 22:44:28 GMT -5
Hopefully MNKD's CC goes much better & provides some insight into the direction & timeline for kickoff.
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Post by 4Balance on Sept 9, 2014 2:29:08 GMT -5
They still have Lantus, right? So if there's a glitch in the launch of Toujeo, wouldn't they go with their old favorite?
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Post by papihoyos on Sept 9, 2014 7:50:50 GMT -5
Does anyone know what time they are on today and have a link?
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Deleted
Deleted Member
Posts: 0
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Post by Deleted on Sept 9, 2014 8:00:23 GMT -5
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Post by liane on Sept 9, 2014 8:01:17 GMT -5
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Post by liane on Sept 9, 2014 8:05:01 GMT -5
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