RE:RE:RE:RE:Type C Meeting Timings Quentin30 - (4/11/2024 10:38:11 AM)
RE:RE:RE:Type C Meeting Timings
Having to hold a Type C meeting means there are questions ONCY has that they wish addressing...
great insight, thathat's the whole point of the meeting stupid.
Yes, it probably is related to potential biomarkers, and whether or not FDA will accept ONCY's suggested biomarker... the text of the new release still states potential, and not CONFIRMED...
Probably? That's exaclty what it's for! That's great news for us.
So, this Type C meeting isn't exactly the one we want to be in...as it would be quicker simply to get on with the Phase III trial design, as per their SPA issued by FDA 6 years ago...
noteable already embarrassed you on this one. Didnt you already day we had abandoned Breast though and it was left behind due to a lack of positive results??
AFTER the FDA has fed back its responses either verbally or electronically (a Type C meeting does not have to face to face), only then can they write their trial protocol, and send that for assessment.
the trial will be be based on the purpose of the meeting! You think they'll not be submitting that or at least started it at the same time dummy?
SO, motormouth... Feedback will be due Jun 24th, and thereafter ONCY will submit its phase III trial protocol... so NO Phase III before Q4 2024.
it could happen next week, you have no idea when the meeting will happen. Latest is 24th June. Bracelet data is due in the next month or so. You worried?
Jeez... and I see the market has reacted accordingly to this fabulous news... down already...LOL
Hahahahah last 30 days Crispr down 20% BYON down 20%!!!! You have no idea what you're doing!!!!