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Post by StevieRay on Apr 1, 2014 18:42:20 GMT -5
I found it strange that Dr. Cooke would vote no for Type 1 but yes for Type 2 based on his cancer concerns. Feel free to throw your drink in my face because I probably deserve it for asking such a strange question at such a great time!
Splash....Spiro I I I was a a a just a a a... ok never mind... |
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Post by liane on Apr 1, 2014 18:48:08 GMT -5
Dr. Cooke is a pedi endocrinologist. Most T1s are diagnosed as children. Whatever drugs they take, they will be exposed to them for 5,6,7+ decades. T2s are often diagnosed much later in life - so shorter duration of exposure to the drug. While TI has not yet shown any big red flags w/r/t CA, the truth is that it has only been followed for a few years, not decades. Dr. Cooke has a valid concern, and I appreciate his integrity.
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Post by alcc on Apr 1, 2014 18:51:46 GMT -5
Agree, absolutely valid concern per your explanation.
I am mighty impressed by the integrity of this panel, and not just because of their vote.
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Post by StevieRay on Apr 1, 2014 18:54:00 GMT -5
Dr. Cooke is a pedi endocrinologist. Most T1s are diagnosed as children. Whatever drugs they take, they will be exposed to them for 5,6,7+ decades. T2s are often diagnosed much later in life - so shorter duration of exposure to the drug. While TI has not yet shown any big red flags w/r/t CA, the truth is that it has only been followed for a few years, not decades. Dr. Cooke has a valid concern, and I appreciate his integrity. I was thinking more in terms of actual people effected. But that is also a great point. I really do admire everyone on the panel who spoke with great intelligence and respect for everyones opinions especially Dr. Smith who had to push back on the request for more clinical trials suggestion. It was great to see honorable people working very hard for the same goal.
It's almost like jury duty I guess but jury duty in most cases is not as demanding. They get paid very little for their input/feedback but it seemed the FDA was taking notes on just about everything they had to say which is a very good sign.
Another drink please for Liane!
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abwo
Newbie
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Post by abwo on Apr 1, 2014 19:02:00 GMT -5
Also tumor in kids grows unfortunately very fast, whereas it's usually slower in adults. So in addition to a longer exposure, it is also potentially deadlier for kids.
Yet I found odd they insisted so much on the Exubera cancer occurences, whereas in my understanding Afrezza is supposed to leave next to no residue in the lungs, when Exubera is. Why should they compare when it's not the same drug, not the same formulation?
Also if you remember that day when Exubera was said to cause cancer, and we dropped so much in a day and all the rest of the competition dropped their inhaled insulin program, at the time Al explained in great length why Afrezza was different from Exubera, all the studies they made to make sure there was no cancer risks as per the FDA recommendations, yet it sounded today as we were judged on this matter only per the Exubera ghost. Too bad...
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Post by liane on Apr 1, 2014 19:06:35 GMT -5
I think TI will do fine. But it's wise to be cautious until they get some long-term studies under the belt. The last thing anyone wants to wake up to is headlines that TI causes cancer.
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Post by babaoriley on Apr 1, 2014 20:41:18 GMT -5
Dr. Cooke is a pedi endocrinologist. Most T1s are diagnosed as children. Whatever drugs they take, they will be exposed to them for 5,6,7+ decades. T2s are often diagnosed much later in life - so shorter duration of exposure to the drug. While TI has not yet shown any big red flags w/r/t CA, the truth is that it has only been followed for a few years, not decades. Dr. Cooke has a valid concern, and I appreciate his integrity. Liane, good explanation; Dr. Cooke explained the reason after the T2 vote, but by that time, we were in celebration mode so I didn't catch his reasoning; I'm sure you're right. And here I figured that after being the lone "1" on T1, he felt a bit sheepish. LOL The way they went after T2 in the last hour of discussion, I really thought the 13-1 vote would be our best, the 14 zip really iced the cake. |
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Post by liane on Apr 2, 2014 4:50:32 GMT -5
Being able to catch the "color" of the proceedings (such as Dr. Cooke's response) was worth the price of the webcast. It's the 1st time that I've done that, and I would not hesitate to do it again. Matese's blog was also helpful. I was not following it line by line, but had it set up on a separate screen. It provided good confirmation for parts I missed or didn't hear right. The webcast provided the first major influx of outside expert opinion (good and bad) on the drug that we've had. Not to discount opinions such as Dr. Skylar, JDRF, etc that we've seen in the past. But yesterday was huge!
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Post by StevieRay on Apr 2, 2014 6:21:53 GMT -5
Being able to catch the "color" of the proceedings (such as Dr. Cooke's response) was worth the price of the webcast. It's the 1st time that I've done that, and I would not hesitate to do it again. Matese's blog was also helpful. I was not following it line by line, but had it set up on a separate screen. It provided good confirmation for parts I missed or didn't hear right. The webcast provided the first major influx of outside expert opinion (good and bad) on the drug that we've had. Not to discount opinions such as Dr. Skylar, JDRF, etc that we've seen in the past. But yesterday was huge! I got my Web Cast at the very last minute. I'm glad I got it too but it seemed I was missing a few slides which was sort of frustrating. I used FdaLive and it cost $200. But I would probably do it gain especially if I have a lot riding it.
Oh my head hurts! Too much celebration last nite!
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