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Post by zzhoskins on Sept 4, 2017 21:40:09 GMT -5
I don't understand. The FDA was already referring to afrezza as "ultra" 8 years ago: "AFRESA is an ultra-rapid acting prandial insulin delivered via pulmonary route." They did it again 3 years ago: "Afrezza is ultra-fast acting insulin administered via inhalation." If the FDA was calling it ultrarapid and ultrafast, why can't MNKD just go ahead and do the same? www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472orig1s000riskr.pdf. |
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Post by straightly on Sept 5, 2017 2:38:06 GMT -5
I don't understand. The FDA was already referring to afrezza as "ultra" 8 years ago: "AFRESA is an ultra-rapid acting prandial insulin delivered via pulmonary route." They did it again 3 years ago: "Afrezza is ultra-fast acting insulin administered via inhalation." If the FDA was calling it ultrarapid and ultrafast, why can't MNKD just go ahead and do the same? www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472orig1s000riskr.pdf. WOW! What a find. I checked and it is true! |
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Post by boytroy88 on Sept 5, 2017 3:13:01 GMT -5
I don't understand. The FDA was already referring to afrezza as "ultra" 8 years ago: "AFRESA is an ultra-rapid acting prandial insulin delivered via pulmonary route." They did it again 3 years ago: "Afrezza is ultra-fast acting insulin administered via inhalation." If the FDA was calling it ultrarapid and ultrafast, why can't MNKD just go ahead and do the same? www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472orig1s000riskr.pdf. In reading that document it seems to me that it wasn't the FDA calling it ultra-fast /rapid but rather MNKD since it was written by MNKD. I think you will need to read/list the approval document to see whether the FDA had actually agreed to those terms (I'm leaning on no since we've been talking about a label change for all these years). |
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Post by zzhoskins on Sept 5, 2017 9:46:22 GMT -5
I don't understand. The FDA was already referring to afrezza as "ultra" 8 years ago: "AFRESA is an ultra-rapid acting prandial insulin delivered via pulmonary route." They did it again 3 years ago: "Afrezza is ultra-fast acting insulin administered via inhalation." If the FDA was calling it ultrarapid and ultrafast, why can't MNKD just go ahead and do the same? www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472orig1s000riskr.pdf. In reading that document it seems to me that it wasn't the FDA calling it ultra-fast /rapid but rather MNKD since it was written by MNKD. I think you will need to read/list the approval document to see whether the FDA had actually agreed to those terms (I'm leaning on no since we've been talking about a label change for all these years). Could be but it doesn't sound like they disagreed with the claim:
"This review by the Division of Risk Management (DRISK) provides comments to thesponsor on the modified REMS submission June 17, 2014. Agency comments on the proposed communication plan REMS were sent to the sponsor June 13, 2014. The sponsor responded with a modified REMS proposal, incorporating most Agency comments. The modified REMS, REMS Supporting Document, and REMS materials were submitted June 17, 2014.
Afrezza is ultra-fast acting insulin administered via inhalation. The application has received two prior reviews from the Agency. The Agency issued a second complete response (CR) letter for this application on January 18, 2011. On October 15, 2013, MannKind Corporation resubmitted the application."
So if the FDA was willing to let it fly then, why couldn't MNKD just give it a try and see if they let it fly again? Does actually putting it on the label do much more?
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