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Post by oscarlonzo on Jun 15, 2015 14:13:37 GMT -5
"Or do you think Sanofi wants to show through the backdoor (not informing ROW), Afrezza is non superior to Humalog?"
Well, correct me if I'm wrong, but the trials that were done to get afrezza approved used lispro:
"...AFREZZA(TM) (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes."
So they've already shown afrezza is "non superior" to lispro. Why would they want to do it again through the "backdoor" or otherwise?
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Post by oscarlonzo on Jun 15, 2015 14:22:37 GMT -5
"...what is the "need" that they would have to broadcast anything?" Well, obviously, there is no "need." On the other hand, it's not a secret since it's right there on clinicaltrials, and now MNKD/SNY are leaving it open to speculation as to its purpose. I mean, most companies, when they initiate a trial, come out and state clearly what they're doing and why, etc, etc. I wonder whether MNKD even knew a trial was in the offing. My general impression gathered from listening to the CFO is that they barely know each other exist, much less what each is doing.
Somebody said something about waiting until the first person was enrolled, but again -- why? It's there on clinicaltrials now; how much effort does it take to throw together a brief PR announcing the event and explaining its purpose?
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Post by tbone on Jun 15, 2015 15:27:46 GMT -5
As of almost noon today, Monday the 15th, I see no press release from either MNKD or SNY about the trial. Why? If it is for an EU application, then it is highly significant news and needs to be broadcast. Would anyone disagree with that? Regardless, MNKD and/or SNY should clarify what the deal is, otherwise its purpose becomes "short" food. However you want to view the trial, the stock rose 3% on 10 million shares. Not a bad reaction for short food. In any event, did not the FDA require further studies surrounding dosing questions? I see this study as serving lots of purposes, none of which involve feeding shorts.
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Post by tbone on Jun 15, 2015 15:38:11 GMT -5
"...what is the "need" that they would have to broadcast anything?" Well, obviously, there is no "need." On the other hand, it's not a secret since it's right there on clinicaltrials, and now MNKD/SNY are leaving it open to speculation as to its purpose. I mean, most companies, when they initiate a trial, come out and state clearly what they're doing and why, etc, etc. I wonder whether MNKD even knew a trial was in the offing. My general impression gathered from listening to the CFO is that they barely know each other exist, much less what each is doing. Somebody said something about waiting until the first person was enrolled, but again -- why? It's there on clinicaltrials now; how much effort does it take to throw together a brief PR announcing the event and explaining its purpose? If anyone here is looking for PRs to bump share price then please go trade penny stocks. This is a real company with a real product that is in infancy stage of revolutionizing diabetes treatment. Why should they PR anything? I'm fine if they never say a word.
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Post by ashiwi on Jun 15, 2015 20:31:40 GMT -5
Clinicaltrials.gov has THOUSANDS of trials. There is NO need for a press release regarding starting a trial. SNY, MNKD and Afrezza are the strong silent types. The patient endorsements and A1c #'s trickling in speak for themselves.
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Post by oscarlonzo on Jun 15, 2015 23:13:14 GMT -5
"did not the FDA require further studies surrounding dosing questions?"
The only requirement for the FDA that I could find was the long term safety study and a pediatric study if MNKD wanted approval for children to use afrezza, nothing about dosing.
"MNKD and Afrezza are the strong silent types." "If anyone here is looking for PRs to bump share price"
I find it rather amazing that, on one hand, a cruise through the various threads shows a great deal of griping about market manipulation, naked shorting, etc, and its effect on MNKD's stock price as well as on afrezza's future, yet when you're handed an item with the potential to give the shorts a serious kick in the bottom -- e.g. a clinical trial that might be aimed at a EU approval -- suddenly it's, "oh, it's okay if they don't announce anything" and "oh, we don't care why they're doing a trial" and "oh, we don't care about stock price here" and "oh, they know what they're doing."
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Post by esstan2001 on Jun 16, 2015 0:32:23 GMT -5
"did not the FDA require further studies surrounding dosing questions?" .... yet when you're handed an item with the potential to give the shorts a serious kick in the bottom -- e.g. a clinical trial that might be aimed at a EU approval -- suddenly it's.... IMHO, it is not a material event until the data is collected and results meet their intended targets, or when the submission is prepared. talking up initiation of a study is just fluff. SNY may also prefer not to tip it's hand to competitors. ...and that's my final answer.
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Post by BD on Jun 16, 2015 2:35:38 GMT -5
"did not the FDA require further studies surrounding dosing questions?" The only requirement for the FDA that I could find was the long term safety study and a pediatric study if MNKD wanted approval for children to use afrezza, nothing about dosing. "MNKD and Afrezza are the strong silent types." "If anyone here is looking for PRs to bump share price" I find it rather amazing that, on one hand, a cruise through the various threads shows a great deal of griping about market manipulation, naked shorting, etc, and its effect on MNKD's stock price as well as on afrezza's future, yet when you're handed an item with the potential to give the shorts a serious kick in the bottom -- e.g. a clinical trial that might be aimed at a EU approval -- suddenly it's, "oh, it's okay if they don't announce anything" and "oh, we don't care why they're doing a trial" and "oh, we don't care about stock price here" and "oh, they know what they're doing." Oscar, you're sounding like a broken record. Can you honestly not comprehend the fact that most of us here are satisfied to allow SNY and MNKD to handle their rollout and research strategies without our feeling the need to armchair quarterback? I've seen your complaints completely and adequately responded to, so how about coming up with some new ones instead of beating a dead horse?
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Post by compound26 on Jun 16, 2015 4:11:24 GMT -5
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Post by liane on Jun 16, 2015 4:22:00 GMT -5
OK, since nothing new of substance has been added to this thread in a couple days, I'm going to lock it.
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