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Biotech / Medical : Madrigal Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (82)3/28/2019 11:39:55 PM
From: Miljenko Zuanic  Respond to 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?



To: tuck who wrote (82)3/28/2019 11:49:01 PM
From: Miljenko Zuanic  Respond to of 138
 
By-the-way, why they need 300 subjects in placebo arm? Are they suspect high level variability and/or placebo response...so there is no surprise factors?

If one have F3/N5 status, who want to be 54 months on placebo????? How will that be accomplished?



To: tuck who wrote (82)4/4/2019 11:16:06 AM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 138
 
Trial did started at single site, S. Antonio, Texas: clinicaltrials.gov