Why Aztreonam was turned down by the FDA

Diane

New member
Heard it through the grapevine that the reason it was turned down was because the FDA had an <b>opthamologist</b> review Gilead's material and clinical research. Because he was not well versed in cf and the nature of clinical improvements as far as cf goes, he did not see that even a few percentage point improvement was even beneficial in light of some of the adverse reactions. Because he did not understand the disease, he recommended denial of the drug.

At this point the CFF and Gilead flew one of our top research guys to testify under oath about the positive clinical outcomes associated with the drug and that the way the said opthamologist interpreted/read the results was not true to the nature of improvements in cf. But the damage had already been done and so it is back to the drawing board.
 

Diane

New member
Heard it through the grapevine that the reason it was turned down was because the FDA had an <b>opthamologist</b> review Gilead's material and clinical research. Because he was not well versed in cf and the nature of clinical improvements as far as cf goes, he did not see that even a few percentage point improvement was even beneficial in light of some of the adverse reactions. Because he did not understand the disease, he recommended denial of the drug.

At this point the CFF and Gilead flew one of our top research guys to testify under oath about the positive clinical outcomes associated with the drug and that the way the said opthamologist interpreted/read the results was not true to the nature of improvements in cf. But the damage had already been done and so it is back to the drawing board.
 

Diane

New member
Heard it through the grapevine that the reason it was turned down was because the FDA had an <b>opthamologist</b> review Gilead's material and clinical research. Because he was not well versed in cf and the nature of clinical improvements as far as cf goes, he did not see that even a few percentage point improvement was even beneficial in light of some of the adverse reactions. Because he did not understand the disease, he recommended denial of the drug.

At this point the CFF and Gilead flew one of our top research guys to testify under oath about the positive clinical outcomes associated with the drug and that the way the said opthamologist interpreted/read the results was not true to the nature of improvements in cf. But the damage had already been done and so it is back to the drawing board.
 

Diane

New member
Heard it through the grapevine that the reason it was turned down was because the FDA had an <b>opthamologist</b> review Gilead's material and clinical research. Because he was not well versed in cf and the nature of clinical improvements as far as cf goes, he did not see that even a few percentage point improvement was even beneficial in light of some of the adverse reactions. Because he did not understand the disease, he recommended denial of the drug.

At this point the CFF and Gilead flew one of our top research guys to testify under oath about the positive clinical outcomes associated with the drug and that the way the said opthamologist interpreted/read the results was not true to the nature of improvements in cf. But the damage had already been done and so it is back to the drawing board.
 

Diane

New member
Heard it through the grapevine that the reason it was turned down was because the FDA had an <b>opthamologist</b> review Gilead's material and clinical research. Because he was not well versed in cf and the nature of clinical improvements as far as cf goes, he did not see that even a few percentage point improvement was even beneficial in light of some of the adverse reactions. Because he did not understand the disease, he recommended denial of the drug.
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<br />At this point the CFF and Gilead flew one of our top research guys to testify under oath about the positive clinical outcomes associated with the drug and that the way the said opthamologist interpreted/read the results was not true to the nature of improvements in cf. But the damage had already been done and so it is back to the drawing board.
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