Your posting history makes it very clear that you are promoting Sierra, a site that has no credibility whatsoever. Off to the ignore bin.
Do you think you will ever be really Kevin? :-). Just kidding - couldn't resist. Those would all be great things to know. Like mnholdem, I'd like to understand where Technosphere and MannKind Technologies fit into the picture.
I was wondering the same thing. They didn't talk specifically about geographies.
I don't think #2 is a possibility. As for #1, it is possible that Afrezza could launch earlier and be targeted specifically against Type 2's until Toujeo is ready. Could be why they talk about a controlled launch. That said, I think the combination launch is pretty powerful.
So tired of hearing shorts will cover tomorrow or whenever. They will cover when they cover, and none of us knows when.
Regarding the tranche loan, I only listened to the Afrezza part and it wasn't mentioned there. Also, the speaker was the head of R&D so his focus was primarily on product - again, at least as far as Afrezza was concerned.
I didn't take away January as the exact date, but he did use the words "beginning of next year". You can listen to a recording of the presentation which is what I did, at least as far as Afrezza was concerned.
Sorry for the formatting - it didn't format in the manner that I had it before I hit the post button.
I find it hard to believe that they would say what they did if they didn't have have assurances of approval shortly.
MannKind will be presenting tomorrow and I'm sure it will focus on Afrezza in more detail. My take was that it was an overall positive one.
See my recap. I listened to the recorded call segment on Afrezza and back-checked my facts. I thought it was a positive presentation.
Afrezza will be launched alongside Toujeo at the beginning of next year.
Both Afrezza and Toujeo will base their differentiation on CONTROL OF HYPOGLYCEMIA, and Afrezza will be targeting users of basal insulins as well those using orals who know they should be using insulin for prandial control.
- Specifically, Zerhouni flatly stated that Toujeo will base its differentiation on hypoglycemia.
- According to Zerhouni, AFREZZA WILL HELP A "SIGNIFICANT" NUMBER OF PATIENTS who are using
ORAL medications where THEY KNOW THEY NEED PRANDIAL CONTROL as well as THOSE WHO USE
A BASAL INSULIN and who need prandial control - but "IN A WAY THAT DOESN'T PUT THEM AT RISK
Zerhouni said that patients would want inhaled insulin.
- Unlike Exubera, which he compared to a fire extinguisher, Afrezza is a "very, VERY clever device."
Regarding the launch which will be at the beginning of next year along with Toujeo:
- It will be a controlled launch, not a huge ramp up.
- "You need to produce it and scale up."
- "It has to be carefully managed"
- You can’t produce all over night
- it’s the same as with biosimilars - controlled launch and then expand
- They are not going to overreach as they need to understand how patients respond
In my opinion this exactly the strategy they should be using. Afrezza will essentially be positioned as a prandial insulin that provides greater control over post mealtime hypoglycemic events, all without the use needles. I also believe that the "controlled launch" being described here is, in part, a strategy of under-promise and over-deliver.