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Post by celo on Dec 3, 2019 17:28:39 GMT -5
what i heard was there was 2 parts,part 1 was dosing part 2 was a phase 3 study. fda agreed to end part 1 and let them proceed to phase 3 hoping to reduce the end point to 26wks instead of 52wks. Shouldn't this be really good news and have it's own personal announcement? Why is it up to individual investors to listen to the conference call multiple times to figure out that the FDA approval for pediatrics is moving along really well? ANNOUNCE IT! Geez it's not like the stock price and shareholder confidence couldn't use a little boost.
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Post by mango on Dec 3, 2019 17:51:43 GMT -5
Sounds like MC alluded to really trying to change the SoC via Peds
Or at least that is what I heard
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Post by Deleted on Dec 3, 2019 18:25:23 GMT -5
what i heard was there was 2 parts,part 1 was dosing part 2 was a phase 3 study. fda agreed to end part 1 and let them proceed to phase 3 hoping to reduce the end point to 26wks instead of 52wks. Shouldn't this be really good news and have it's own personal announcement? Why is it up to individual investors to listen to the conference call multiple times to figure out that the FDA approval for pediatrics is moving along really well? ANNOUNCE IT! Geez it's not like the stock price and shareholder confidence couldn't use a little boost. I don't think it's a definite decision that the FDA will cut back to 26 weeks.
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Post by sayhey24 on Dec 3, 2019 18:53:21 GMT -5
what i heard was there was 2 parts,part 1 was dosing part 2 was a phase 3 study. fda agreed to end part 1 and let them proceed to phase 3 hoping to reduce the end point to 26wks instead of 52wks. Shouldn't this be really good news and have it's own personal announcement? Why is it up to individual investors to listen to the conference call multiple times to figure out that the FDA approval for pediatrics is moving along really well? ANNOUNCE IT! Geez it's not like the stock price and shareholder confidence couldn't use a little boost. MC is waiting for the protocol to be accepted. It sounds like its almost a done deal but its not time to assume anything. What I thought was additional good news was him talking about "the new classification" - ultra acting. They are getting the word out in February. If this really happens many here have been waiting for that for years.
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Post by letitride on Dec 3, 2019 19:27:53 GMT -5
Was the audio for the presentation poor or is it my hearing?
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Post by MnkdWASmyRtrmntPlan on Dec 3, 2019 19:38:09 GMT -5
Poor is an understatement. Awful. Jeesh! Piper Jaffray can't afford a decent microphone?
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Post by goyocafe on Dec 3, 2019 19:47:30 GMT -5
Poor is an understatement. Awful. Jeesh! Piper Jaffray can't afford a decent microphone? I thought it was the feed, but the replay is bad as well. If they made the recording from the same feed we all had, that would make sense. Otherwise, it would be a local issue with microphones or some other equipment.
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Post by porkini on Dec 3, 2019 19:53:22 GMT -5
Poor is an understatement. Awful. Jeesh! Piper Jaffray can't afford a decent microphone? To be fair though, because these services are run through some sort of streaming service, network issues could be partially to blame as well. Not only is there network packet loss to account for, but jitter (the order in which packets are sent/received if ever) as well. Same reason that anyone who has participated in a video conference and sees screen artifacts (i.e., frozen or random pixels) during the conference. I would say listen to the playback version to see if it sounds the same, my guess, probably not (probably better than the streamed version).
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Post by mango on Dec 3, 2019 20:51:35 GMT -5
Shouldn't this be really good news and have it's own personal announcement? Why is it up to individual investors to listen to the conference call multiple times to figure out that the FDA approval for pediatrics is moving along really well? ANNOUNCE IT! Geez it's not like the stock price and shareholder confidence couldn't use a little boost. MC is waiting for the protocol to be accepted. It sounds like its almost a done deal but its not time to assume anything. What I thought was additional good news was him talking about "the new classification" - ultra acting. They are getting the word out in February. If this really happens many here have been waiting for that for years. Definitely heard that. Did you also hear the part about changing the SoC via peds? Talk about a Double Whammy!
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Post by agedhippie on Dec 3, 2019 22:24:59 GMT -5
MC is waiting for the protocol to be accepted. It sounds like its almost a done deal but its not time to assume anything. What I thought was additional good news was him talking about "the new classification" - ultra acting. They are getting the word out in February. If this really happens many here have been waiting for that for years. Don't hold your breath for ultra-rapid making a difference until there is trial data to prove that it does. On the plus side Lilly and Novo will have a huge incentive to ensure that it is seen to make a difference.
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Post by sayhey24 on Dec 4, 2019 6:26:26 GMT -5
MC is waiting for the protocol to be accepted. It sounds like its almost a done deal but its not time to assume anything. What I thought was additional good news was him talking about "the new classification" - ultra acting. They are getting the word out in February. If this really happens many here have been waiting for that for years. Don't hold your breath for ultra-rapid making a difference until there is trial data to prove that it does. On the plus side Lilly and Novo will have a huge incentive to ensure that it is seen to make a difference. Aged - MC named it - "Ultra Acting". I never liked the name "Ultra Rapid Acting" but "Ultra Acting" sets it apart. I have been holding my breath for a long time but he said they have 5 to 7 studies which will support this for February. A few more months at this point won't kill me. Mango mentioned about SoC changes. Maybe its related to the new category which would be exciting. We know the Indian study for the T2s is soon to start. This is the big one which you have wanted for years and is the one which should place afrezza right in the mix of T2 care. Of course it should be Step 1 but get getting it in for starters is a big win. Not a 2020 change but 2021 looks real. It will be interesting to see the CGM they use for the study. MC said 2020 is the year of the T1 and this time next year we should have pediatric approval which is huge.
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Post by agedhippie on Dec 4, 2019 8:47:27 GMT -5
Aged - MC named it - "Ultra Acting". I never liked the name "Ultra Rapid Acting" but "Ultra Acting" sets it apart. I have been holding my breath for a long time but he said they have 5 to 7 studies which will support this for February. A few more months at this point won't kill me. Mango mentioned about SoC changes. Maybe its related to the new category which would be exciting. We know the Indian study for the T2s is soon to start. This is the big one which you have wanted for years and is the one which should place afrezza right in the mix of T2 care. Of course it should be Step 1 but get getting it in for starters is a big win. Not a 2020 change but 2021 looks real. It will be interesting to see the CGM they use for the study. MC said 2020 is the year of the T1 and this time next year we should have pediatric approval which is huge. I don't think they will use ultra as the description, and not because it isn't or anything like that but rather because of the confusion it causes. We already have fast acting (Regular insulin believe it or not!) and rapid acting (RAA), which has people asking which is quicker and what does quicker mean? That said, the other insulin makers will want it because it's a marketing tool. The protocol and plan for the India trial still has to be even filed. I am curious to see if they do use CGMs because it's an unnecessary expense for Cipro.
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Post by lennymnkd on Dec 4, 2019 9:06:38 GMT -5
How can they not use CGM’s ? Only works to our advantage in a big way . I would be very surprised if they did not .. from back in the day with Matt P / this whole thing was predicated on the cgm being implemented in our success.. the tool too prove our true superiority.
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Post by longliner on Dec 4, 2019 9:07:20 GMT -5
Aged - MC named it - "Ultra Acting". I never liked the name "Ultra Rapid Acting" but "Ultra Acting" sets it apart. I have been holding my breath for a long time but he said they have 5 to 7 studies which will support this for February. A few more months at this point won't kill me. Mango mentioned about SoC changes. Maybe its related to the new category which would be exciting. We know the Indian study for the T2s is soon to start. This is the big one which you have wanted for years and is the one which should place afrezza right in the mix of T2 care. Of course it should be Step 1 but get getting it in for starters is a big win. Not a 2020 change but 2021 looks real. It will be interesting to see the CGM they use for the study. MC said 2020 is the year of the T1 and this time next year we should have pediatric approval which is huge. I don't think they will use ultra as the description, and not because it isn't or anything like that but rather because of the confusion it causes. We already have fast acting (Regular insulin believe it or not!) and rapid acting (RAA), which has people asking which is quicker and what does quicker mean? That said, the other insulin makers will want it because it's a marketing tool. The protocol and plan for the India trial still has to be even filed. I am curious to see if they do use CGMs because it's an unnecessary expense for Cipro. When you are the Usain Bolt of insulin, it doesn't make sense to run the race without a timer. Yes you will win, but the rest of the world won't recognize your speed.
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Post by agedhippie on Dec 4, 2019 9:41:29 GMT -5
... The protocol and plan for the India trial still has to be even filed. I am curious to see if they do use CGMs because it's an unnecessary expense for Cipro. When you are the Usain Bolt of insulin, it doesn't make sense to run the race without a timer. Yes you will win, but the rest of the world won't recognize your speed. I would agree, but the pediatrics trials were not done with a CGM and that's a case where I think the PR/Marketing win would have been significant regardless of the larger trial outcome (non-inferior would have been buried by "look it's normal").
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