SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Immunomedics (IMMU) - moderated
IMMU 16.44-7.3%3:59 PM EST

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: Renmanco1/13/2020 8:08:33 AM
2 Recommendations

Recommended By
jhcimmu
Smoke Reader

   of 54039
 
Reminder: Here is what is currently being re-examined:

“The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated."

Let's not forget that getting this right will/should make future submissions somewhat easier as the CMC trio will have already been approved per the current submission and just updated clinical drug safety and efficacy data needs to be added unless, of course, future submission specifics will require new CMC procedure inputs.

Once IMMU's team gets this all done (finally) correctly this time, they will have enhanced their skills for future submissions....at least that would be my expectation.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext