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 : Madrigal Pharmaceuticals
MDGL 412.28-1.6%Nov 3 3:59 PM EST

 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: tuck who wrote (82)3/28/2019 11:39:55 PM
From: Miljenko Zuanic   of 138
 
From the patent applications database I think that they did upgraded large scale manufacturing process for 3196, post Roche process. P3 should be run with API/drug supply from finalized *validated* (three batches) process, otherwise IF they change process they will need bridge/bioavailability study post P3.

So far, from 10Q/K SEC reports I did not detected contract manufacturing efforts/expense....so how can they process P3 without all this preparation???

Their P3 protocol PR is standard (I could wrote it without investigators meeting), so today PR is nothing more than BS. Market did not buy-it, and I am not surprise nor disappointed.

PS: Will be interesting how many sites will be open when they posted trial protocol?
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext