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RETT! Fastest Approval EVER!!
On the Rettsyndrome.org call 2nd question. "IS THERE AN NDA FOR Anavex" This is why Rett Syndrome is hot ?? listed and an FDA priority. There are no approved drugs and parents of Rett children are pounding the FDA to speed up the process!! IR was saying on good results in this 001 Rett trial results, if good, we file this year! As soon as parents see an FDA filing (parents are watching ??)has occurred that will set a storm of calls and letters to the FDA for immediate approval!! Normally under Accelerated approval I expect an FDA review date by July if filed in December, but Accelerated approval allows the review date to be early!! Opdivo had Accelerated approval with a June PDUFA date and got approved in April. I could see this as a record speed approval like late May!! This has nothing to do with stockholders! On amazing results the FDA will be under tremendous pressure from parents with Rett Syndrome to get the 1st ever Rett drug approved for sale! Anavex will need to produce enough for thousands of patients very quickly!! Just bring on amazing results!!
Testing new name. Can't wait for rett results!!
TEST. . CAME from stocktwits. Trying this board out.
My assumption is later August but no way of knowing exactly except it's soon for sure now.
They gave results on all patients in the trial. We know what the overall results are in including placebo (that gets DCVAX upon relapse) and the group that got DCVAX all the time. Lifespan for the total is approvable (you didn't see that? That is out. We don't have specifically how each group did to be able to compare the 2 arms. That comes after unblinding of the trial.
Cool! Yeah. They have good results so far. Looking forward to more specifics
Really nice data so far. My question is, so in the ITT population (all) MGMT unmethylated OS is 19.8, while average OS in unmeth is 14 months. Methylated was great with 35.1 OS while normal OS is 21 months. Question is how many unmethylated vs methylated started on DCVAX and how many on placebo. We won't know until unblinding. If an unmethylated (poor prognosis) patient gets DCVAX initially do they do better getting DCVAX earlier??
Watching now! Thanks!
Wow! Love to see that! Hopefully awesome results!
Aug 18, 2011. DCVax will be ready in 2 years! Today July 2019 we will have results in 2 months most likely. .
Linda powers. .
Back to NASDAQ? $175 mil in warrant money? If results are good, the stock could be 1.5 and 500 mil in warrants could be executed at .35 so I guess $175 mil in cash to NWBO! Bring this back to life!
The biotechnology hot list!
Sure NWBO is 1st! BB market.,. The science will be good or bad no matter what market it's in!
NWBO results .after all these years! Finally by August likely! Only 600 million shares later! This still can be $1.5 if results are good! Glioblastoma looking likely on good results here.,
AUPH and TOCA these 2 have ph3 results by year end!! AUPH had overwhelmingly positive ph2 and TOCA is breakthrough therapy! Looking for $15 to $20 on both!
TINY PLX is ahead of all the rest with the lowest market cap going for ACCELERATED approval on a potential 800 mil per year drug! PDUFA date to be set early 2020 for JUNE 2020. This can run to $2.5 by June 2020. There is a large milestone payment on Approval also!
RTTR I give it a 60% chance of positive results for it's phase 3 drug in early October. This can hit $2 before results! Could be $5 if results are good.
Thanks! Now results!! We will see.
8 months life span after recurrence. I got that from here. . Glioblastoma is an aggressive brain cancer that kills two-thirds of patients within five years. A patient's outlook with recurrence of the disease is considered to be weeks or months. ... Patients receiving VB-111 survived 15 months on average, compared to 8 months on average for patients receiving Avastin alone.Oct 1, 2015
Follow-up survival data from the Information Arm patients who did not qualify for the Phase III trial are encouraging and appear consistent with the blinded interim data from the trial. In the group of 25 Information Arm patients who had actual or apparent early tumor recurrence, the follow-up data showed that 40% of the patients lived for 3 years or more, 20% of the patients lived for 5 years or more, and 12% of the patients are still alive at 7 years.
AFTER recurrence, 8 months is about how long you could live. . Unbelievable after taking this drug 10 out of 25 people lived for years!
Chance of positive results? 85% in my option. I know the Placebo effect comes into play for past results! It is possible that someone given a drug can think they will get better and live longer just because they think they are cured! So this trial has the 2 arms to remove that placebo effect idea. . The 40% in the group (not part of trial, but reported in June) lived MUCH longer than expected! Nobody lives that long after glioblastoma recurrence. Can't imagine a "placebo effect" that strong
Chance of results by Sept about 80% and by Dec 100% just slam it or jam it! It's about time!
So many years, who is actually happy here. But results can give this a 2 billion dollar market cap!
After so many years!! Now ALL I care about is results!
I sold RTTR 3k gain! $1 to $2 if good results here.,
Yes! $1 to even $2 on good results!
MRNA is doing something similar,(individualized treatment) we are just further along! With good results this can be over 1. MRNA has over a 4 billion market cap! Not for long, while we rise like crazy if we have positive results!
Woodford waited years! Watch this soar! Oh well.,., I assume August is the month!
DO or DIE binary event! MM's knocking stock down after hours right after close every day! This is a blinded trial! Nobody knows what results will be. This is over $1 or under .10soon!! Holding through.,.,
I bought back at .28 will buy more!
Results of ununblinding? AUGUST?
My guess $1.25 per share!
hoping for results any day now! should be about time!
I MUST have a DATE! For me to buy I need to see NWBO state that complete results will be released and those results will be the final determination for the end of the phase 3 trials.
sure NWBO can go over $3 or $4 but that price is what I would expect after results. The company would become valuable after phase 3 results and the stock may continue higher after .. At this point I watch the stock and wait for NWBO to give us the when and where data will be released. Most companies choose a scientific conference.
GREAT results coming/share toilet paper now!
I will buy this stock as soon as we get a date for data to be announced. I am confident NWBO has highly favorable statistically significant results. Why? HTBX uses any cancer cells, radiates them and gets the cells to spew proteins that encourage the immune system to act, and it does, but NWBO has a significantly higher patient Specific approach that should substantially increase the effectiveness. So YES I predict BIG success here, at the same time NWBO needs financing and share toilet paper is in effect, which will continue, but when results come out this can still be 3 or 4 per share! ! So I wait for a date for when results will be released and buy then. .
GIVE me a date for Data release! I would buy this back!! I had sold at .41, but I think this company has good results! !
The good, the bad and the-ugly-wait-continues.
Good .. lifted the hold and trial was not stopped for lack of efficacy. The FDA feels good about the trial.
Bad .. several months before complete results! They can't even tell us what the first endpoint results were?? Why not!!
Ugly .. chances of a capital raise or another secondary is substantial before results come out.
Wait for Trump/approval is easy!
After Trump changes FDA regulations, this will be approved easily
Bid.01/200ask? News time?
How long is 'soon??'
If BMY could just use opdivo/yervoy other potential partner companies would be out .
Now the list of potential partner companies still is large . .
But BMY has to go down the list and see what other options it has.
Yeah. . It's good . Not decisive. . But it makes things more interesting
BMY gives up on opdivo/yervoy combo.
Every other company doing something with opdivo has a better chance now!
"So you're saying there's a chance! "
Well, it's better now. .
6.62 per share Conversion Rate for the Securities is 151.4142 shares of Company common stock per $1,000 principal amount of Notes.
10 million dollars is 1.5 million shares. .
Let them convert.
Yeah. Some reason I think they would want to change that agreement!
Tad-agreed! She is no penny stock trader. .she just wants to cure patients
Thanks MD! cool. . Some contact
How about a piece of results!
Like PLX did. .Just some statistic, just to keep investors interested.
It will leave us wanting more. .
But, NWBO has fallen silent.
Seems they closed their PR department down til results are in.