One of the most mysterious things to me is how the voting questions ended as they were. Why were they not amended by JW? The ADCOM was doomed to fail but somehow the AA vote was close. Putting the investment part of this aside, this should make for a fascinating decision.
Absolutely key question enabler. Its truly an interesting situation. Its not like there's a lack of treatments available, which would argue for a p3. It may simply depend on the strength of the numbers.
A few on this board including and especially the aforementioned makes me want to leave. He's even called me a soft basher. My lord... This place needs to be about opinions, good and bad, as long as there is some logic behind it.
I hate to say it VJ, but I think I'm with you. Doesnt help us long term. The mini pumps are short lived. I dont think they add true investor exposure but rather volatility.
I would be ok having a reasonable scientific discussion, but there is nothing to the post. It is general with no substance. Has no purpose. I agree, ignore.
Bballgm and Avav. I think you are both right. The question is whether they can create a combo dna vaccine and dMAb for Pseudomonas. Is it even worth going after? But this is a good question worth asking and the end result will create value no matter what.
Perhaps it's too early to project to clinical use, but it's interesting regardless. My recall with dMab is that a patient would need to get re-immunized after a few months to maintain immunity. The question then would be is this better for a therapeutic or preventitive use? I would actually argue at least in the beginning, this may be better for therapeutic use in clearing pseudomonas. As a preventative, the target patient population would be those that are immunosuppressed, chronically and severely ill, or bed-bound and prone to pneumonia. Immunosuppressed would include those post-transplant, HIV, or certain genetic conditions. Perhaps you go after both indications? In going after a preventative label, one would need to get all treating facilities comfortable with EP. This will be lengthy albeit a necessary process at some point in the near future.
So many years from now, but fun to think about. It is likely 3100 what pave the way to acceptance of EP making uptake of subsequent Therapies easier.
You may be right. That would obviously be fantastic. But Ive often seen IND submission and acceptance be PR'ed, so I'm not sure what's up. A P1 trial start would be hugely positive
INO would need to submit an IND first
• 30 days from the day the packet is sent to
– Will hear back from FDA for clarification or
– Clinical HOLD or request for modification
– If no word is heard, the investigator may begin
the study after 30 days; “No news is good
Avav, you are correct that an anti-inflammatory agent such as Humira, might do the trick. The difficult part will be to try to figure out how to limit systemic effects, and that's beyond me. Neuroinflammation is a difficult topic.
Exactly. Exactly! There has been growing theories that inflammation plays a larger role in these disease processes, rather than a peripheral one. For decades, investigators have gone after plaques (beta-amyloid) and tangles. For decades, they have failed. It is time for a new approach.
Google: "Are dementia and Alzheimer's actually due to an immune response? New hypothesis says yes" by John Murphy. Another trial Inovio needs to start ASAP. Talking about lucrative and serving mankind!
If there was a leak, volume would be huge. Very unlikely although not impossible for the fda to leak. Price can easily go both ways before a binary event. You can argue it from whatever direction you want, but many may want out rather than risk a short position here.
hi hung, last update for this indication was 11/15. Its been 6 mths. Will they provide an update? Not sure anymore
LOL. Seems like there is conflict between courts and the SEC. There may also be some regional differences. Not sure I got a clear answer. Perhaps a lawyer on the board can help?
Of course wisker... and that's why I posted it. It's not as simple as a 'yes, no', they must disclose a takeover offer.