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Pretty disappointing outcome to Excellence trial. Can they still file for approval?
Nunya Leo.
Yup. I didn't write that there was something "new" - simply that Roy asked a direct question, got a direct answer, and apparently decided (differently from you and BL) that the additional data was a non-issue.
Christopher Missling directly answered the question posed by Soumit Roy. Roy subsequently issued a $58 per share target price for AVXL shares.
There was no mention of an "issue" but simply another follow up visit and associated data. Could there be an issue? Maybe. You would have to assume that though - no problem was mentioned. The company said when they have the data (not resolve a problem) then they can release TLD.
There was no issue. Read the transcript.
Am I sure? No. But that is an educated guess. Takes a tier 1 pharma co like Biogen about 3 months to prep the NDA after data is complete. I give Anavex 2 extra months.
Q3 for Rett? I think April/May or sooner.
That would be none of my business and I would not guess or ask. AVXL is a a great bet - but wouldn't advise anyone else how much to invest in anything.
There is no need to announce a rolling submission until the last of the application is submitted. At that point, the PDUFA date will have been set and that is considered material.
Macbeth was a character in a play written by Shakespeare 425 years ago. Shakespeare did not anticipate anything in the way of sigmar1 agonists - or the 24/7 bellyaching of shorts on this message board.
George, there are at least 3 of us on this board who own over $2.5m. Would guess there are more. No reason to name names.
They are presenting on 11JAN.
They raised some money from a pharma partner and paid a big dividend...but, no, never generated any operating revenue.
Same CEO, yes. BOD of course experienced turnover, like all boards.
He did not say that the delay was due to an "issue". Read the transcript. The followup safety data is pro forma.
Pre-commercial biopharm is a ride. IMO lots of slack should be cut to all of them. SAVA has a 25 year track record of simply not delivering - it talked up its opioid for over a dozen years and then that failed. Will simufilam be different? Maybe. Hope so. But the same kind of management pumping is in force as before.- at least a yellow light. And the OL data and the short blinded extension data was...no bueno.
You are writing as if anyone hear cares what you want. Your incessant whining earns you no respect. Try acting like an adult and adding some value here instead of complaining that Anavex isn't run like an oil and gas company.
If you are a shareholder, then you want the company to release a PR into the trading void between Christmas and New Year's Day? Or do you want good news released next week when everyone will see it?
You are not great at learning or listening Kund: sure some deadlines have been missed - this is very, very common - but the goods have all been delivered even if late. This is the way pre-commercial biopharm works. Biopharm that already generates revenue ALSO misses all its dates...they simply don't share them because they can talk about sales and marketing.
Kund, you must not have invested in many (any) pre-commercial biopharm companies if you think delays are unique to AVXL.
It has always been the case that schedules slip. Next life sciences investment you could keep that in mind Kund.
It is pretty clear why the illuminati haven't been able to take over more than their local masonic lodges.
You are making the (probably) incorrect assumption that misinformation (intentional or otherwise) was issued. What you are posing is a variant on "when did you stop beating your wife?"
You are a moderator Kund. Please act like an adult.
You could take a vacation, too, Kund! Probably do you some good.
"might" and "unsure" are words that make sense from you, Kund. In this case you know "might" = zero chance and "unsure" = you actually don't know. Why don't you save these nothing-burger posts for a nice long weekend when no one is here to see them?
I *think* you are wrong - but it doesn't mean you are. The probabilities, given the company's repeated statements (and specific claim that they deliberately chose odds ratio as the measure) make me believe the company. Were it to lie, regardless of ultimate approval, there would be a real cost.
Thanks, good post. I take issue with your certainty regarding trial failure primarily because the company said it hit all its endpoints and has access to all the data and analysis and is on the record as saying it hit all the endpoints and the EMA apparently agrees...whereas (this is not meant to be mean) you have not seen the SAP nor seen the data and analysis. Could you be right? I have a STEM degree so I would say yes, but the chances that you are right are very, very slim. If you are right then you should line up as lead plaintiff in a class action because you would deserve to get a larger share than others.
Kund, all endpoints were met. Several people have replied to you specifically with the releases that showed all endpoints were met. So, obviously, you are incorrect about the $15b-$20b market cap being a certainty. But you knew this already, of course. A pre-commercial company is pretty unlikely to see a market cap of $20b. One might be bought out for $15b (2x-3x market cap)...and hopefully that is a possibility here.
FWIW, it is not true that "the first-listed" measurements are the ones given more weight. There may be several primary endpoints and they don't rank above one another regardless of the order in which they appear in the statistical analysis plan. Of course, the secondary endpoints are considered less important than the primary endpoints. Your friend may have been simply referring to primary v secondary and it just didn't communicate clearly for whatever reason. (Hopefully my understanding of what you wrote was accurate - it may not have been.)
Wouldn't think of trolling you plmr. Absolutely will point out how vacuous your thinking is from time to time, however.
Checker, you do indeed attempt to confuse. Few things you write are backed up by data or links. You have negative opinions you love to throw out there ad nauseum. That is OK - we all know your schtick now.
My posts are not for you plmr. You and "investor" and "checker" and other people who post to try to confuse people and get them down on the company and their progress don't really matter. I post for people who may not understand the regulatory processes or the constraints on a pre-commercial company with respect to communication. I don't think you and a handful of other people here are sincere - or maybe it is that you are not capable of understanding this industry. Either way, you are not my concern.
In the end, if a company has a good molecule then it wins. It isn't about management (it matters but not as much as the data) and it isn't about hitting a specific date in time (sooner is better but later is no big deal.) There is no effective and safe therapy for AD - except for 2-73. There is no safe and effective therapy for Rett - except for 2-73. It appears that 2-73 will likely help with Parkinsons. And with FragileX. And with Angolans. And, I think, with ALS, MS, and other progressive neurological diseases. 3-71 appears to be effective, too - we just don't know how effective yet.
You can keep yelling that the cook is terrible because the cake is not out of the oven yet, but I don't see how that helps anyone. It is more productive to point out that the data is outstanding across the board, that regulatory processes take time, and the company is in solid fiscal shape. This latter kind of note serves the retail investors that come here and to other stock message boards much better than to criticize a pre commercial biotech company for not being a natural gas producer.
Am rooting for your delusions plmr.
I just read the message this note responds to: full of opinion and innuendo but no facts. There is name -calling. There are unfounded assertions. There is nothing in your note to signify that you understand life sciences processes or fundamentals. Too bad, because with some intellectual/logical discipline combined with effort and experience, you could add value here someday.