Post by
N0taP00p on Nov 25, 2024 12:38pm
BTD+AA with Quarterly Release this week?
They don't seem to be casting their net wide for funds ie. just enough to survive a month or two each time, probably from the same set of investors who've drunk the science Kool-Aid like many of us. By now, they should be close to receiving a yes or no on BTD. If the FTD designation has been used effectively, the FDA should already know everything they need to know, given the pre-BTD Q&A that happened recently with senior FDA folks. Let's hope they get it in time for the quarterly release. If on the other hand, the FDA asks for more data, we might be dealing with a new FDA team by mid next year.
Comment by
rhodiumd on Nov 25, 2024 12:51pm
No. BTD approval should under no circumstances be "diluted" alongside other news or announcements. It should be a standalone NR. Period.
Comment by
menoalittle on Nov 25, 2024 2:07pm
BTD application is newsworthy enough to be a stand alone announcement, say nothing about approval... which would definitely deserve a trading halt.
Comment by
Kayz88 on Nov 25, 2024 1:54pm
I think the quarterly earnings report contain a snippet that says "We submitted the BTD application to the FDA for approval on Insert Date " Now we wait for news of approval. I doubt that they'll let us know they got approval along side a quarterly report, timing doesn't make sense. The FDA has 60 days to respond to the BTD submission.
Comment by
menoalittle on Nov 25, 2024 2:04pm
I think you're full of baloney