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Post by herman on Mar 17, 2014 9:16:23 GMT -5
Clinical Utility will be the reason. Essentially, FDA will say there is no defined benefit over existing treatments. It's a rigged game and the big money will prevent this from getting to the market here in the US. Al will be forced to take this offshore.
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Post by babaoriley on Mar 17, 2014 9:22:30 GMT -5
A cheery first post!
Like an aftershock to the earthquake we just had in LA!
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Post by oncostat on Mar 17, 2014 9:24:28 GMT -5
We will see who's right and who's wrong soon. :-)
Oncostat
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Post by liane on Mar 17, 2014 9:24:26 GMT -5
Just so all our members know, this member has been here before under the aliases "piccolopete" and "proctologistpete". These former accounts have been disabled following our rule of no multiple accounts.
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Post by 4allthemarbles on Mar 17, 2014 10:04:43 GMT -5
Herman- Take your nonsense to the yahoo board or anywhere else that will put up with you. It will not be tolerated here.
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Post by herman on Mar 17, 2014 10:06:43 GMT -5
My opinion, I think the deck's been stacked. If it turns out the AdCom is for anything else but labeling advice - watch out = hedge yourself.
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Post by liane on Mar 17, 2014 10:29:36 GMT -5
Certainly, everyone is entitled to their own opinion. Best if you can provide some basis for your thoughts.
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Post by thekindaguyiyam on Mar 17, 2014 10:36:03 GMT -5
Just so all our members know, this member has been here before under the aliases "piccolopete" and "proctologistpete". These former accounts have been disabled following our rule of no multiple accounts. thanks Liane. I think this name proctologistpete is a better fit for where his head is at. It's always good to know who's who I know. Iyam
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Post by StevieRay on Mar 17, 2014 10:57:11 GMT -5
Clinical Utility will be the reason. Essentially, FDA will say there is no defined benefit over existing treatments. It's a rigged game and the big money will prevent this from getting to the market here in the US. Al will be forced to take this offshore. I was not even going to respond to this nonsense but I thought others might benefit by the discussion of "Clinical Utility". So now Afrezza has no clinical utility even though Afrezza has demonstrated in many clinical trials that it mimics a normal healthy pancreas by suppressing prandial glucose excursions immediately. For any of those who might for even a second think Afrezza has no clinical utility then you probably don’t know what “clinical utility” is or you are probably attempting to mislead readers.
Here is little write up on the subject.
clinical utility - International Journal for Quality in Health Care
“What is clinical utility? Utility literally means usefulness; so clinical utility could mean the usefulness of an intervention for, or in, clinical practice. Utility is also associated with utilitarianism—that is, the ethical doctrine of achieving the greatest good for the greatest number. In this sense, a clinical outcome, judgement, or practice might be justified according to a balance of benefits and drawbacks. Pertinent questions for judgements about clinical utility would thus be (i) what are the components of usefulness, benefits, and drawbacks; (ii) how might we define and measure these factors; (iii) how should they be weighed against one another; and (iv) usefulness and relative benefit for whom? To begin the task of answering some of these difficult questions, I will explore what is, and what should be, included under the auspices of the term clinical utility. I will explain how the concept is commonly used and present two studies that have extended the concept beyond this common usage.”
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Post by spiro on Mar 17, 2014 11:19:55 GMT -5
StevieRay, this Herman guy is obviously another Boogeyman. Boogeymen don't know that Afrezza, by lowering the number of severe hypoglycemic events, will save countless numbers of lives each year. OK, maybe the FDA doesn't care about saving lives, we will soon know.
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Post by mannmade on Mar 17, 2014 11:31:43 GMT -5
Once again it is a statement with no factual basis to back it up by someone whose agenda must be questioned. Seems that's the best that someone like this can do to try and discount the value of Afrezza and it's chances of being approved by the FDA. I would have a lot more respect for someone who could make a statement and then back it up with facts. An open and fair discussion is always welcome... But McCarthyism is not...
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Post by StevieRay on Mar 17, 2014 11:38:40 GMT -5
Spiro, I’m very confident that the ADCOM and FDA will overwhelmingly vote to approve Afrezza which we all know will improve the quality of many lives worldwide not to mention all the cost savings from all the complications (loss of limbs, nerve damage, blindness, organ damage, etc….) brought on by out of control blood sugar. I’m looking forward to MannKind’s post approval “Script Count” Boogeyman. In exactly one month if all goes as planned I suspect the Script Count Boogeyman will show up, but I’m not too worried now that I know you’ve got a pretty good working remedy that casts an evil spill on all those evil doers!
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Post by notamnkdmillionaire on Mar 17, 2014 12:01:30 GMT -5
One thing is for sure, Herman is going to need a proctologist to remove Al's fist from his ass when Afrezza is approved.
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Post by nemzter on Mar 17, 2014 12:01:40 GMT -5
Clinical Utility will be the reason. Essentially, FDA will say there is no defined benefit over existing treatments. It's a rigged game and the big money will prevent this from getting to the market here in the US. Al will be forced to take this offshore. Rapp?
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Post by liane on Mar 17, 2014 12:03:21 GMT -5
nemzter - I had the same the same thought.
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