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Re: Botox carry-over
For you longs out there: is there any carry-over from Botox--what I mean is, though botox and daxxify are different, they are both neuromodulators, so could any conclusions between drawn about the upcoming PDUFA from the fact that Botox is already approved for use in CD (and Spasticity)?
Dare I say--no, I don't, not in bios--CD and Spasticity are low-hanging fruit?
If CD is approved this week, it bodes well for Spasticity, which is moving into Ph3.
Plasticity is a huge indication. Just looking over the pivotal Ph2 data, which is moving forward into Ph3. Seems like great data. Anyone disagree?
https://www.businesswire.com/news/home/20210222005783/en/Revance-Announces-Positive-Topline-Phase-2-Data-Supporting-Advancement-of-DaxibotulinumtoxinA-for-Injection-for-the-Treatment-of-Upper-Limb-Spasticity
What's the TAM for CD? How realistic is it? There are also other sNDAs they could go after; another one, in fact, is moving into Ph3. Are these realistis (read: profitable) markets?
Still hard to wrap my mind around the price decline. I was in this before Daxxify approval, and sold at $18 or so. Watch it climb to $35, cursing myself and my termity along the way. And now here we are, back at $18. I got back in around $25; been averaging down since, currently at $21. Will add if it drops upon approval.
What are the odds of Cervical Dystonia approval? Would seem quite high, considering everything we know. Any apprehensions? Thanks
New here, after many years away. Anyone have a read on the upcoming PDUFA? Seems to be a slam dunk: sNDA, solid Ph3 data, Boxox approved for Cervical Dystonia (different drugs, but neuromodulators all the same). Won't be an issue with manufacturing. Anything else you see that might give FDA pause? Full disclosure: I've been adding quite a bit post-er.
I'd like to hear a bit more from doc on the data;
You know what's funny? I am long AVXL; but I am also honest. I have been around biotech way too long not to be fooled by a pr that claims something relevant clinically without including data to back it up. Just flies in the face of reason. Sorry. It's what my eyes have seen over the years and what my brain concludes; and, until proven otherwise, I remain skeptical.
here's what I think is going on: Data is a dud, while Rett's comes through.
I don't buy it.
You can talk about waiting for this or that, analyzing this or that (btw, it sure seems from your post they have a lot of information on the trial: why not give any specifics? Wait--don't tell me: they are waiting on more data, yah, right), but if data had been outstanding, they would have disclosed it; they would have given a number--any number--any number of patients, one, two, ten--"Patient 101 improved XXX on..."
Think about it: instead of saying, vaguely, that data will be shared at..., wouldn't it have been more intriguing, market-grabbing, if they had given two or three statistically significant data points to pique interest or create suspense?
Someone on this board said Missling released the non-press release because investors were asking for it. Okay, he satisfied them--right?
Bottom line: The press release was vague. There might have been some encouraging signs/lines, but nothing even close to what some people on this board think.
so since when does the CEO of a micro-cap dispel doubt by releasing a pr without data? Just a stupid move on his part, that will produce the opposite effect: more uncertainty.
Let me ask you a question if you believe in your words: Have you backed up your certainty with more shares?
I'm, in fact, in avxl; have been for years, even before the first read-out--years before most people on this board had even heard of ANAVEX. But, I must admit, having followed biotech forever, that the fact that he put out a pr without data it concerning, to say the least.
You said 'topline' statement. LOL! What the hell does that mean? That's a new one on me.
it seems few people find it odd that a clinical-stage biotech releases a press release of a trial whose data is "statistically significant" but then doesn't include any data. And then has a conference and still doesn't mention data.
What do I know? I was born a skeptic. You just don't see this very often. Either the release of a pr was premature or Missling is struggling significantly to put a positive spin on non-data.
Otherwise, he would have said something; he would have given some numbers. It's just the way it is. Rarely is it any different in biotech. And one has to ask: why is it different this time?
you can also read too much into something. I read excitement, enthusiasm, hope, but, as far as clinical progress goes, I read nothing. Not trying to be cute here. Could you please point out a phrase that unequivocally demonstrates that patients are improving while on the drug?
but there is no indication that the drug is actually helping the children, yet. Or am I missing something?
I don't really know, but you would think so. Biotechs are never shy about announcing good data.
Who says there's any news? How about saying, during the CC, that the news isn't ready yet?
Agreed.
Fair enough. Sorry.
fascinating eight minutes. Having had CRC, I am well aware of the benefits a healthy diet has on the body. Though the verdict is still out on the benefits of a plant-based diet, a few years ago a study was presented at ASCO showing that Stage III patients who consume nuts, along with increased physical activity, have a significantly lower chance of cancer recurrence.
https://www.ascopost.com/issues/april-25-2018/nut-consumption-in-patients-with-colon-cancer/
How long? Three months?
Probably will see 2 dollars. I will buy if it drops that low.
are you buying at these levels? I nibbled at 2.70.
Fair enough. Sounds reasonable.
re Rett trial. "Manage expectations"? Why can't they just say? Why didn't anyone ask during CC? Just leaves the market wondering, doubting. Don't know how this helps to manage expectations.
A bit confused on enrollment of 20-patient Rett Trial. Where does it stand? Is it fully enrolled? Will we see data in Q1?
I think I'm going to hop back in.
I say it runs. Too much momentum building. In different times, before the merger, I believe traders and retail investors would drop it, retail concerned about dilution, traders toying with the huge float, etc., etc. This time it is different. If the ASCO data is confirmed (we will get data on 24 pts; 15 were in the abstract), the merger will go through; and if the merger goes through, IDRA will neither have a huge float or dwindling cash. I can almost feel it, I've been around this stock so long. I say we see 2.50 over the next two weeks; not saying it will stay there; just saying it will touch there, esp. if the data is good on June 4 and the investor show that follows. No other biotech--not NKTR, not DVAX, not Checkmate--have the data IDRA has on refractory patients. It has fast-track designation as well. Things are going to get interesting as they reach full enrollment toward the end of the year. They're looking at 60 patients; right now they might have 30-35. With seven sites up and running, each site needs to enroll two per month for two months and they have it. Needless to say, I am optimistic. I've loaded; I await.
i don't know, longs, but this doc sounds scary level-headed, commonsensical, speaking with authority. Gee, almost as if he didn't have an agenda.
Bingo!
Any thoughts on DVAX abstract/data?
can't wait for the 13g
my guess: both of you are wrong.
Hey guys! Back in.
some things never change...
Any real company and Missling would be fired. If milestones were revenue Anavex would be deep in the red. Clown CEO.