$IBIO There are absolutely no negatives in the entire report, as many people are saying on this board. "We have never submitted an NDA or BLA to the FDA or comparable applications to other regulatory authorities and do not expect to be in a position to do so for the foreseeable future." (10-K, p. 21) NDA = New Drug Application. Guess what iBio-400 needs before it is approved for commercialization? An NDA. Shocking, I know, but for some reason the FDA usually likes to approve drugs before companies can sell them. But why question it, right? I'm just a negative guy who apparently doesn't understand how things work. Now go ahead and tell me to sell. I need to block some people. Or you can simply acknowledge the risks as identified, stay invested, but with your eyes wide open so you can actually make informed, reasonable decisions based on real information (like I do) instead of rampant, unfounded speculation.
  • 22
@iBiopreneur Exactly, or why they aren't planning on doing it in the foreseeable future. I want them to be able to foresee that, and if they can't, I'd like to know why. They've repeatedly stated their other drugs are all in preclinical. It can take years to get a drug to P3. 400's a huge asset. Do they plan on licensing it out? Marketing it themselves? Do they need to do more testing? What are the timelines? We know they won't have enough money to execute their business plan. They stated it. Ok. So what's the plan? Could 400 support operations next year, the year after, or when? If they're going to mention that they renewed their activities on 400, and they're going to provide an update on the rest of the pipeline (as they did), then it piques my curiosity when something is omitted. Omissions create risk. And it wasn't mentioned in the 8-K either.