research reports and media, page-1403

Very interesting...thanks again Gan_Gans...

Its a dilemma...Tanezumab has the efficiency...up there with our results....BUT those safety concerns is the sand grain in the mouthful of rice...We know particularly the FDA is about safety..its their number one concern...PLUS this OA indication is not a limited disease, there are millions that are suffering ...careful consideration is required, no wonder they have been testing and trialing for so long.

Same in our case...it's not like the FDA have said bahhh...

• Bridging study - no worries
• Accepting of just the Japanese PK study - all ok, its enough
• Bare minimum 1000 patients in the trial is fine
• Even Dosing regime is fine...

Nah they want it all properly done and sure some of these are recommendations but PAR are smart enough to understand that these are really MUSTS. We want to IMPROVE our odds of success...no matter if we think we are a sure winner, thats irrelevant..we want to MAXIMISE our chance of success..no one has the time OR the funds to start again if something goes wrong, something is missed or something is sloppy...

(Imagine, we all cry if we may miss one simple deadline by a few weeks...what would be our reaction if after read out FDA say...all ok so far but what about...this......that...you need ANOTHER study to measure this before we can proceed...We wouldn't be able to bare it....this is what we must mitigate).


YES sure it adds millions to our costs...it adds time...so much time to design a trial properly...to ask for a Type C...to request a PRE IND...but it will be worth it in my opinion once we have it all proven....we are getting closer.

DYOR