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See msg#259268.
The potential changes at FDA probably mean that AF is flat wrong.
Interesting and informative! It means that there will probably be drastic changes at FDA in evaluating the effectiveness of a biologic therapeutic, including using secondary endpoints as a basis for approval.
That would probably be a official declaration of the revival of NWBO.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
Guidance for Industry
DECEMBER 2019
Draft
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2019-D-4964
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FDA-2019-D-4964
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Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness. This guidance complements and expands on the 1998 guidance entitled Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (the 1998 guidance).
The 1998 guidance was issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105–115), which stated that the substantial evidence requirement for effectiveness, which had generally been interpreted as calling for two adequate and well-controlled trials, could also be met by a single trial plus confirmatory evidence. The 1998 guidance, therefore, provided many examples of the types of evidence that could be considered confirmatory evidence, with a specific focus on adequate and well-controlled trials of the test agent in related populations or indications, as well as a number of illustrations of a single adequate and well-controlled trial supported by convincing evidence of the drug’s mechanism of action in treating a disease or condition.
FDAMA thus introduced a specific new area of flexibility in the evidence needed to support effectiveness, but there are many other characteristics of the evidence supporting effectiveness that can vary (notably, trial designs, trial endpoints, statistical methodology), and evidence that varies in such ways potentially can provide substantial evidence of effectiveness but because of these characteristics may provide greater or lesser certainty. These characteristics also deserve consideration and were not discussed in the 1998 guidance. FDA’s consideration of these various designs, endpoints, and analyses which can differ in the strength of evidence they provide, reflects the Agency’s longstanding flexibility when considering the types of data and 39 evidence that can meet the substantial evidence requirement.
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products
taking my first position in 2 years. If there is any substantial change in this whole thing, it would be the addition of Dr. Kevin Duffy.
Duffy must have reviewed everything he could before joining NW Bio. He must have seen something that makes sense to him as a significant figure in the field. If failed, it could be a stain on him. He bet on it, and I also bet a few dollars.
Good luck!
Just a few more words: made a huge mistake here due to lack of due diligence. Realized this the moment I saw the photo of its CEO. I just don’t trust him, not for a minute, not scientifically nor as a human being. Besides, he has been with the company forever and his enthusiasm probably has long gone. This company needs some new blood to go on.
They should push or have pushed for the combo trial. That's how to grow the company. It seems though they just sit on their fat asses waiting for the interim analysis, which could be good or bad. It's a toss.
That makes them very suspicious.
Interim analysis last year was released in Feb. Do you think they would wait for 290 events?
Did they really talk about 100% survival? Do you have a link to it?
Well, our opinion doesn’t count. I don’t think they really care about the small investors like us. Too bad they pissed the big ones on the street already. When institutional ownership is under 10%, chances are the stock gets bullied by shorts.
AMEX for example.
Personally I think R/S was a much worse choice than moving out of NASDAQ to a different market.
In addition to FDA's "suggestion", R/S was a very bad move. It invited tons of shorters into the game. The downtrend was about to reverse prior to R/S but hell R/S killed it. Hope this settles sooner than later.
If there was development on patent, ARGS should have issued a news so everyone is on the same page, not being played by shorts like this.
Let’s rephrase it- They may reverse split to make the shithole even bigger to suck more people in
Hahaha
Hahaha you shitman made my day
This company has basically zero value if not negative imo. People hanging here just for that manipulative pop that might never come. Shorting is the only game except I never short a stock.
Last time I witnessed a r/s was with MACK. It dropped 15% and then stabilized. It looks like poising for a up trend.
Hope ARGS do better than that b/c of the upcoming catalysts.
I used to have a limit buy order @ .13 to double my position somehow I didn’t put one in yesterday. Lost a golden opportunity.
let's say 25% of volume is dilution,diluted shares would be 33.5M. So it would be at least by the middle of Feb,2018
agree. And it is a bad sign as they move their spread range down to below 0.04.
Me, too. It’s my largest holding ever. One cent = $3K.
Maybe I am just insane.
That won’t happen until April or May.
maybe a good chance to buy. I am seriously thinking of doubling my position here.
Shares reported represent an amount sold to cover the tax liabilities of the reporting person pursuant to a 10b5-1 sales instruction related to a restricted stock award agreement dated August 30, 2017. Acquisition of the restricted stock was previously reported in Table I of the reporting person's Form 4 on August 31, 2017.
IMO, not a big deal.
just type any symbol and you will find a few this kind of articles. They don't mean much. Making an investment decision based on this kind is ... unwise.
ARGS won't be a pump & dump game. No need to pump. I would get out of this if there is a pump campaign going on.
Can't agree more. Hope they can really get this to the finish line.
GLTY
see post#151114 if you care.
There were quite a few graphs posted t in the past showing basically the same thing.
I am trying to find an explanation for the obvious crossover of the curves in the graphs, not just because I want to argue.
Don't you see that? What's your explanation? I don't think one can just ignore it though because a subset of patients died sooner.
Thanks AVII. In addition, there was a noticeable differential effect in your graph, likely due to the negative impact of repeated leukapheresis on patients immunity. The strength of the differential effect in the real data set of the trial could be much greater as the model used to generate this graph might have been significantly biased in favor of NWBO. Thus, the so called "long-tail" might become less meaningful.
[img][/img]
"seems..."
I just quoted what others have said.
the question would be whether the tail is long and being held high enough to not only compensate but significantly surpass the initial negative impact of the repeated leukapheresis on patients' own anti-cancer immunity and the survival.
wahhhhhhhhhhhh
GALE stock price will be 3000% higher!!!
I am all in.