RE:RE:RE:RE:RE:RE:RE:Nothing like some 'leaks' on the FDA Resubmission Every clinical program has to be proceeded by a "good" preclinical yet many still stumble/fail, it's a risky business.
Wino115 wrote: I'm afraid part of that is that the pre-clinical stuff was all packaged nicely, told a compelling story around safety, efficacy, novel aspect, etc.. Back then there was a lot of detail in all sorts of areas --in fact, that pre=clinical is still telling that level of info. But the human trial is where they hit a stumbling block. There wasn't really much they could "tell" as it wasn't living up to it's billing as far as the theorized MOA/science. There's something still in there, but whether these changes or a different chemo bomb or the combo approach is the answer is yet to be determined.
I agree they could talk about what they think and just put caution around it all until there's an answer on their questions. But that only would get you so far anyway. On NASH, they've laid it all out and gotten approval for a smaller "starter-version" of the trial (the 2b interim read part), so they've done what they can science-wise and now it's all about someone in drug development wanting to explore the fat-buster, safe approach as an additional therapy potential or even combo potential as Madrigal sees first revenues chugging in. We know there's hair around aspects of it, so you'd have to give any partner a fairly compelling deal. As we look back in hindsight, it just becomes glaring that they did not take advantage of the $12-14 share price spike and load up a future treasure chest to do things. By way of example, when a few of those medical names got tied up in the whole bizarre GameStop/Robinhood trader frenzy, a few raised a ton of money off it. They just couldn't pass it up and jumped (look at Bionano an imaging company) , They've been set to do all sorts of investments on their own now. That was a mistake on the part of the Board, CEO, CFO and I would guess with 99% confidence that had a real VC/Biotech Inv Banker type been on the Board, they would have jumped up and down convincing them you have to seize the moment and worry about the "what for" later. Anyway, here we are.
Lastly -- the oncology drug market is showing strongly in the quarterly reports --notably Merck/Keytruda and Astra/Enhertu keep showing strength as they roll out geographically and in other indications. BMS also did ok as did SeaGen. So cancer drugs are definitely the hot growing space as a lot of new technology developments open up the ability to treat more patients or treat the disease better. So money will be looking if you have something. But loads chasing that ...just need one!