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Post by silentbob on Apr 10, 2014 17:19:12 GMT -5
Some real gems in their filing & on their website: - Relative bio-availability of about 12%, less then half that of Afrezza - None of the technology is actually theirs, the most crucual part is licensed from Aerogen. - They will try for Type2 only at the start, probably to save money. - Extremely limited amount of trials done so far. They hope to 'bridge' to the Exubera data with a single trial. I doubt it will work considering the major differences in device and drug composition. Maybe in Europe, but that is far from certain. - Hexameric human insulin. About a similar profile as RAA, so expect equivalent hypo risk (and carb counting etc...) - Breath speed matters; there are lights to indicate if users are breathing at the right speed. - Liquid insulin dripped into the device. It seems this could cause all kinds of fungus/infections to grow in the device. They will probably have to do tests related to this and design cleaning protocols. Filing : www.sec.gov/Archives/edgar/data/1596126/000119312514137204/d620119ds1.htmI just skimmed through it, didn't read the whole thing, but I saw enough. When you combine the low bio-availability with the need for a complex device (three crucial suppliers parts: 2x pump and 1x nebulizer), their COGS will be astronomical compared to Afrezza. More complex handling, complex carb counting, larger device, hypos, slower to peak means they will have to price LOWER then Afrezza... not sure if that is possible with their COGS. I must admit it looks like an improvement over Exubera, but it's still dead in the water compared to Afrezza. Not even close...
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Post by harshal1981 on Apr 10, 2014 17:27:07 GMT -5
They are capitalizing on the buzz created around Afrezza... Any day I would welcome an innovation. However, they are yet to release any meaningful data. would love to see how they are pricing the IPO.
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Post by spiro on Apr 10, 2014 17:52:07 GMT -5
I wonder if their insulin would require refrigeration?
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Post by seanismorris on Apr 11, 2014 0:45:45 GMT -5
Dance looks interesting, but...
I don't see a dosing advantage, device advantage, or hypo advantage over Afrezza.
If they were competing with basil insulin, I'd be more excited.
But, because they are completing with Afrezza...well good luck.
As for attempting to bridge Exubera data, well that's a huge red flag, as it was a clearly inferior product.
Exubera today wouldn't make it through the FDA review (even minus the cough).
I would like to see their clinical trial data...
But, my guess is someone is trying to capitalize on the buzz surrounding Afrezza, so that their 'Angel Investors' can get there money back.
If I was looking to invest I'd want to make sure 100% of the 75mil goes to clinical trials and administrative expenses.
Also, I'd like to see where they came up with the 75mil as it doesn't seem nearly enough.
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Post by silentbob on Apr 11, 2014 5:39:48 GMT -5
I wonder if their insulin would require refrigeration? They claim it is stable at room temperature for 4 weeks. I haven't seen any data to back it up though. Their formulation is supposedly a pure preservative free and sterile solution of human insulin. The dispenser is supposed to keep the insulin from being contaminated, I assume. However: - Stable according to what definition? Within what parameters? How much degradation did - Room temperature is not a clear temperature range. What about summer? What about a hot car? What about carrying it in your pocket? - What about bacteria at the nozzle of the dispenser? It is for use of up to 4 weeks! - How much testing was done to back up this claim?
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Post by silentbob on Apr 11, 2014 5:40:58 GMT -5
I wonder if their insulin would require refrigeration? They claim it is stable at room temperature for 4 weeks. I haven't seen any data to back it up though. Their formulation is supposedly a pure preservative free and sterile solution of human insulin. The dispenser is supposed to keep the insulin from being contaminated, I assume. However: - Stable according to what definition? Within what parameters? How much degradation did - Room temperature is not a clear temperature range. What about summer? What about a hot car? What about carrying it in your pocket? - What about bacteria at the nozzle of the dispenser? It is for use of up to 4 weeks! - How much testing was done to back up this claim? And it most certainly will require refrigeration while "on the shelf"...
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Post by thekindaguyiyam on Apr 11, 2014 13:46:23 GMT -5
I just called up Dance for info. They are located in the Bay Area. No human answering the phone only a message machine. Wrote them an email asking if the insulin required refrigeration. Seems like you answered my question. However, room temperatures vary quite a bit. So how does it work at 85+ degrees... IF they reply to me; I'll pass along their answer. The unit they use looks like a vaporizer designed to smoke marijuana. At what price does the individual pay when in need if the electronic device fails? Give me something that has as few moving parts as possible to eliminate that possibility.
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Post by brentie on Apr 11, 2014 14:03:13 GMT -5
"At what price does the individual pay when in need if the electronic device fails? Give me something that has as few moving parts as possible to eliminate that possibility."
Give me an inhaler you don't have to clean, just use it for two weeks and throw it away. Couldn't be easier.
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