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Post by silentbob on Apr 7, 2014 5:09:22 GMT -5
Up till now I have believed the FDA was genuinely trying to follow its mission statement, combined being bureaucratic and risk averse it seemed sufficient cause for the past events.
With all the incorrect and unfair remarks in the briefing documents I started to have some doubts about the FDA reviewers, but still I would expected them to be swayed by the ADCOM panel and public opinion.
With this added delay, it just seems a lot like the FDA does whatever it can to push MNKD back. A three month delay is pretty much the maximum it can extend (unless MNKD submitted masses of additional data, which is unlikely).
Maybe I'm a little late to the party but I'm really starting to question the FDA's motives now.
I'm not in a position to do anything about it, as I'm a EU citizen, but for you Americans among us I would suggest writing a letter to your congressman.
Some eyes on the FDA might encourage them to act in the interest of the general public for a change...
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Post by cusop on Apr 7, 2014 6:18:46 GMT -5
I am really sorry to say this, but I think you are right, I feel that the Adcom was not what they expected and now they are under pressure (FDA). My suspicion is that the methodology that the FDA uses to determine efficacy for insulin was challenged by Afrezza and the committee. Which will require further review. For those of us who were siting long and holding firm this a kick in the crutch. But for shorts this will be heaven
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Post by jpg on Apr 7, 2014 6:23:11 GMT -5
Maybe I am naive but I don't see any nasty intentions in this by the FDA. They are very very slow and are actually faster then they have historically been. I would think this is more indicative of a culture of not caring about anything else then their narrow vision of reality. Very frustrating and certainly not a vote of confidence for investing in biotech at large. The least the FDA could do is stick to deadlines.
End of rant...
JPG
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Post by esstan2001 on Apr 7, 2014 8:27:53 GMT -5
A one month delay would have given them 6 weeks to work out the label details, which should have been enough time. IMO, it is possible that they have to call on their best in house diabetes expert(s) to resolve in committee the difference between the A1C metric having been used and the FBG excursion data (and who know knows what, & how much new data was provided by Mannkind)- I was hopeful that a 1 month delay would suffice; but after all, this is our government we are dealing with...
Good suggestion from silentbob to write our congress people to keep on the pressure.
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