HER2 Support Group Forums - View Single Post - Does anyone have news about the TDM1 announcement?

phil · 02-13-2013, 07:56 PM

i think it will be anyday, one clue may be FDA Commissioner is going to be the featured speaker at Mass Biotech Coucil Annual Mtg. march 14, 15. and featured drug presentation is " Antibody Drug Conjugates ", the fancy name for t dm-1 type drugs. Boston is now a world center for biotech. is she really coming all the way to Boston to give bad news to the pharma co's. i think not. why have they waited to the end of review time ? can only speculate :
because they can ? , flexing thier regulatory muscles ? , or looking for any s/e to play up as an excuse for thier mis-mgt. of this special drug ? or , maybe they plan to treat it as the special drug it is , and approve for all who progress on herceptin ? the last one is a stretch for This FDA , they havent thought outside their 1980's box with this drug since 2010.

02-13-2013, 07:56 PM	#4
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: Does anyone have news about the TDM1 announcement? i think it will be anyday, one clue may be FDA Commissioner is going to be the featured speaker at Mass Biotech Coucil Annual Mtg. march 14, 15. and featured drug presentation is " Antibody Drug Conjugates ", the fancy name for t dm-1 type drugs. Boston is now a world center for biotech. is she really coming all the way to Boston to give bad news to the pharma co's. i think not. why have they waited to the end of review time ? can only speculate : because they can ? , flexing thier regulatory muscles ? , or looking for any s/e to play up as an excuse for thier mis-mgt. of this special drug ? or , maybe they plan to treat it as the special drug it is , and approve for all who progress on herceptin ? the last one is a stretch for This FDA , they havent thought outside their 1980's box with this drug since 2010.