Tommysdad:
The FDA does the job they get paid very well to do.
I do the job I get paid to do . I get no special praise for doing what i get paid for,, thats my job.
If I am persuaded by an outside force to alter my end product,, I should be subject to reproach,, as should they.
i do not blame them for every rejection,, in fact i have never made any statement about them in public ,, until DRMD.
Of course the product was not identical,, they were told it did not have to be.
IF that was the real reason for the denial,, why did it take a year for the decision?? Why didn't they just say "hey, this don't have the
good stuff in it". Why did they "extend " the period for public comment and put off answering DRMDs request for a decision.
DRMD never tried too fool the FDA that their product was the same from the time they submitted it. If the rule is hard and fast that the product has to be exactly the same ,, no exceptions,,The FDA could
have said so day one , and saved DRMD millions.
No, while we agree on most points ,, I do not agree that this decision was not tainted. It was political and had a lot of internal resistance within the FDA because , sure, some of the people in the FDA are real people and wanted to do the correct thing based on "science". They
were not able to do so. Also i do not believe them to be so tainted that they would approve a "bad' drug .
I do hope those actually interested in finding real merit, win this time and I hope DRMD has some plans to turn the spotlight on the FDA at the proper time .
CRDoug |
