RE:RE:FDA flexible with AKRO phase IIb/III AKERO as per PR are going to present the results of their study at an upcoming scientific meeting followed by the trial protocol, the last meeting was September 14(Morgan Stanley's conference) I am not sure which meeting they are referring to but it won't be soon and the IND probably late 2020.So the PR was just an update keeping investors sweet for now.
THTX as per CC a couple weeks ago will submit the IND in coming weeks so there is timeline difference which could be the reason why they didn't say anything about their latest interactions with agencies close to submitting the application.
qwerty22 wrote: So what AKERO are doing here is opening a window into the conversations they have had with the FDA, this is not the IND getting approved they still have to finalize their protocol. In effect this is the same announcement that Thtx just put out except they told the market what the regulators are thinking not what management and KOLs think. That to some extent is what was missing from the thtx cc. Thtx must also have written feedback from their discussions, why did Thtx not reference that? Why is SPCEO learning what the regulators think from 2nd/3rd hand sources? What did the regulators say that makes management confident about Ph3?
Having had that moan then it's great to see this flexible attitude toward NASH
SPCEO1 wrote:
https://www.prnewswire.com/news-releases/akero-therapeutics-to-continue-efruxifermin-development-with-innovative-adaptive-phase-2b3-clinical-trial-design-based-on-fda-written-guidance-301137157.html