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Sorry thiose were April $7.5 Call: April $5Call was $0.75 starting on 11/17/15 and rose to $2.62 on the 19th.
On 11/17-18 they sold for $0.50 -$0.70-$1.15-$1.35-$1.55 range
Someone seems to offer an unending supply @$6.22-3 point, if demand could take it above $6.40 that would set some support below and break us out of this $5.40 to $6.3 range. i really would like to sell that $7.5 Dec Call but Missling could surprise us with something and i prefer to be long.
Hard to say...1 for 250 reverse split... but the Judge said shareholder's value = to $0.042..... Low oil prices puts that in doubt.
14 patients had completed 12 wks by CTAD, could, would they present partial updates?
Edny Inui @BMTEdny Nov 7
$AVXL ANAVEX2-73 14 pts have reached wk 12 of part B; primarily reporting part A today #ctad2015
georgejjl Sunday, 11/15/15 10:55:07 AM
Re: dayneyus post# 36733
Post # of 39621
Anavex completed enrollment of all 32 subjects in the current Phase 2 trial by September 28, 2015. Therefore, all 32 subjects will have completed at the first 12 weeks by December 21, 2015.
http://www.anavex.com/wp-content/uploads/2015-11-07_Anavex_Presentation_CTAD_2015_Macfarlane.pdf
They can evaluate 12, 24, 38, and 52 weeks
If it Peaks above $6.40 today we may see $6.98 topped.
Beautiful isn't it!!
The way were moving now you will own some stock.
How would this be packaged All inclusive or by individual disorder?
So much for selling $7.5 calls ... get taken out in a blink of the eye!!
Very Great Observation! Correct me if I am wrong, isn't the LPC agreement triggered at or above $7.00 range?
Thinking of selling Dec covered calls now that things have slowed 28 days to expiration. Whats a near term high without exciting news? I've trace 2 trends from $0.61 low to recent highs and lows, and two Horizontal trends, get $6.97 high?
Will Do!
Just buy some cheap puts for 1/2 your holdings; Nov $5.00 Put is @$0.15 = $150 for 1000 share insurance,. The Big guys are selling insurance to scared longs they may only tease it down near in the money but will come in before expiration to raise it out of the money.
I did very well buying Leaps on SPPI when it was hot.
205 Dec $7.5 call on the bid, big boys trading this.
Might add his margin will be about 50% of that $37K -$18500 in margin and you can keep the stock.
When did they start Option trading. Great buy, this beyond great .
Much appreciated Thanks!
Hi Rkmatters
http://www.abstracts2view.com/sabcs15/view.php?nu=SABCS15L_527&terms=
Can you please clarify the..."... Mean comparison with tetanus toxin...":
T cell immunity to naturally processed HER2 proteins occurred in 94% of patients. The mean number of T cells specific for each peptide, post vaccination, ranged from 349–528 T cells per million peripheral blood mononuclear cells (PBMCs).
The mean number of T cells specific for whole HER2 protein was 783 T cells per million PBMCs compared to a mean of 898 T cells/million PBMCs specific for the foreign tetanus toxin.
and this Contrast
In contrast to T cell responses, modestly increased antibody immunity to HER2 occurred in 35% of patients, consistent with the T cell-inducing design of the vaccine.
Conclusion: Our results show that it is possible to develop vaccines with broad HLA coverage that circumvent natural tolerance and induce tumor antigen-specific immunity in the vast majority of patients.
Accelerated Approval: "..Accelerated approval allows approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
"....Accelerated approval allows approval of a drug that demonstrates an effect on a “surrogate endpoint ”that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
III. CONCEPTS FOR EXPEDITED PROGRAMS
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
The programs that are the subject of this guidance, fast track designation, breakthrough therapy designation, accelerated approval, and priority review, are summarized in section IV and described individually in detail in sections V, VI, VII, and VIII. All four expedited programs represent efforts to address an unmet medical need in the treatment of a serious condition, which is discussed in the following paragraphs.
A. Serious Condition
1. Whether a Condition Is Serious
FDA intends to interpret the term serious as it has done in the past for the purposes of accelerated approval5 and expanded access to investigational drugs for treatment use.6 A serious disease or condition is defined in the expanded access regulations as follows:
. . . a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self- limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible if it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.7
Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
Frequently Asked Questions: Breakthrough Therapies
http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm
1) How many requests for breakthrough therapy (BT) designation has the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) received since the Food and Drug Administration Safety and Innovation Act was signed into law on July 9, 2012?
CDER and CBER Breakthrough Therapy Requests Received
CDER Breakthrough Therapy Designation Requests
CBER Breakthrough Therapy Designation Requests
CDER and CBER Breakthrough Therapy Approvals
CDER Approvals for Breakthrough Therapy Designated Drugs
CBER Approvals for Breakthrough Therapy Designated Drugs
CDER and CBER Breakthrough Therapy Withdrawn After Granting (WAG) and Rescinded
CDER Breakthrough Therapy Designation Withdrawn After Granting (WAG) and Rescinded
CBER Breakthrough Therapy Designation Withdrawn After Granting (WAG) and Rescinded
2) What are the benefits of a breakthrough therapy designation?
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. Section 902 of FDASIA requires the following actions, as appropriate:
holding meetings with the sponsor and the review team throughout the development of the drug
providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable
taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment
assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager
involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review
3) What other programs does FDA have to expedite drug development for serious conditions?
FDA has various programs that are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions. These expedited programs help ensure that therapies for serious conditions are available as soon as it can be concluded that the therapies’ benefits justify their risks, taking into account the seriousness of the condition and the availability of alternative treatment. These programs include breakthrough therapy designation as noted above, fast track designation, accelerated approval, and priority review.
Fast Track Designation: Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Designation may be granted on the basis of preclinical data. A sponsor of a drug that receives fast track designation will typically have more frequent interactions with FDA during drug development. In addition, products that have been designated as fast track can obtain rolling review.
Accelerated Approval: This program can be used for speeding the development and approval of promising therapies that treat a serious or life-threatening condition and provide meaningful therapeutic benefit over available therapies. Accelerated approval allows approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
Thus, the accelerated approval pathway is most often useful in settings in which the disease course is long and an extended period of time is required to measure the intended clinical benefit of a drug, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Nevertheless, even after the drug enters the market, the sponsor may be required to conduct post-marketing trials to verify and describe the drug’s clinical benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.
Note that a drug that has received a breakthrough therapy designation or a fast track designation can be eligible for the accelerated approval pathway, if the relevant criteria are met.
Priority Review: As part of its commitments in PDUFA V, FDA has established a review model, the Program. The Program applies to all new molecular entity NDAs and original BLAs, including applications that are resubmitted following a Refuse-to-File action, received from October 1, 2012, through September 30, 2017. For applications filed by FDA under the Program, the PDUFA review clock will begin at the conclusion of the 60 calendar day filing review period that begins on the date of FDA receipt of the original submission.
This review designation is determined at the time of a BLA, NDA, or efficacy supplement submission. Any drug, including those that have received a fast track designation, breakthrough therapy designation, or those being evaluated for accelerated approval, can be granted priority review, if the relevant criteria are met.
4) What are the differences between the criteria for breakthrough therapy designation and fast track designation?
Breakthrough therapy and fast track designation programs both are intended to expedite the development and review of drugs for serious or life-threatening conditions, but there are differences in what needs to be demonstrated to qualify for the programs. A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.
5) Does a sponsor have to request breakthrough therapy designation in order to be considered for the designation?
A sponsor needs to submit a request for breakthrough therapy designation in order to be considered for the designation. In some cases, FDA may suggest that the sponsor consider submitting a request for breakthrough therapy designation if: (1) after reviewing submitted data and information (including preliminary clinical evidence), FDA thinks the drug development program may meet the criteria for breakthrough therapy designation, and (2) the remaining drug development program can benefit from the designation.
6) Where can I find the “Guidance for Industry” on breakthrough therapies?
The final Guidance for Industry: “Expedited Programs for Serious Conditions––Drugs and Biologics” published on May 30, 2014, and can be found at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
7) Where can I find the CDER Manual of Policies and Procedures (MAPP) on the management of breakthrough therapy-designated drugs?
MAPP 6025.6 “Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics” was published on July 29, 2014.
8) Where can I find the CDER Manual of Policies and Procedures (MAPP) on the review of a marketing application for a breakthrough therapy-designated drug that is receiving an expedited review?
MAPP 6025.7 “Good Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics That Are Receiving an Expedited Review” was published on March 9, 2015.
9) Where can I find the webcast and presentations from the FDA Public Meeting: Breakthrough Therapy Designation: Exploring the Qualifying Criteria held on April 24, 2015 in Washington, DC?
The webcast and presentations from the FDA Public Meeting: Breakthrough Therapy Designation: Exploring the Qualifying Criteria can be found at: http://www.brookings.edu/events/2015/04/24-fda-breakthrough-therapy-criteria.
10) Can a sponsor submit a request for breakthrough therapy designation for multiple indications of the same drug?
A breakthrough therapy designation applies to a combination of a drug (either alone or in combination with other drugs) and the specific use for which it is being studied. A separate breakthrough designation request must be submitted for each proposed development program (i.e., each indication for a drug (or drug combination)).
11) Can a request for a breakthrough therapy designation be submitted for a combination product?
A breakthrough therapy designation can apply for a combination product (drug-device, biologic-device) as long as the primary mode of action in the combination product is a drug or biologic.
12) Can a product be granted a breakthrough therapy designation if another product has already been granted breakthrough therapy designation for the same indication?
One of the criteria for breakthrough therapy designation is the drug may demonstrate substantial improvement over existing (or available) therapies. A product that has been granted breakthrough therapy designation and is not approved or licensed in the U.S. is not considered available therapy.
13) Whom should sponsors contact if they wish to discuss the potential for their product meeting the breakthrough therapy criteria?
The review division managing the investigational new drug application (IND) for the drug in question is the sponsor’s first resource for questions related to the development program of the specific drug, and its potential for breakthrough therapy qualification. If an IND is not yet open, then the contact would be the review division that manages the particular therapeutic area of the proposed indication.
14) Would a clinical trial for a drug that has been designated as a breakthrough therapy generally have to enroll fewer patients prior to approval?
After a development program is designated as a breakthrough therapy, FDA will work closely with the sponsor to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate. An efficient trial design typically would help minimize the number of patients exposed to a potentially less efficacious treatment, which could translate to fewer patients enrolled in clinical trials that support marketing approval. Regulatory standards to demonstrate safety and efficacy must still be met.
15) May a sponsor submit a request for Special Protocol Assessment (SPA) for a drug that has breakthrough therapy designation?
Breakthrough therapy designation and SPA are two independent regulatory pathways. Therefore, a drug designated as a breakthrough therapy is eligible for SPA if the protocol meets the criteria for SPA. Conversely, a drug for which an SPA is under review may be considered for breakthrough therapy designation, if the breakthrough therapy designation criteria are met.
16) Will FDA announce when a drug has been granted breakthrough therapy designation?
FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).
17) If a drug is denied breakthrough therapy designation, is it automatically reviewed for fast track designation?
Fast track and breakthrough therapy designation programs are separate programs and require separate requests for FDA consideration.
18) To what section of the electronic Common Technical Document should a sponsor submit a request for breakthrough therapy designation?
A sponsor should submit a request for breakthrough therapy designation to Module I, Section 1.12.4 "Request for Comments and Advice” of the electronic Common Technical Document.
19) Can a sponsor submit a request for breakthrough therapy designation to a pre-IND?
A sponsor should submit a request for breakthrough therapy designation with the submission of a new IND, or as an amendment to an active IND. Requests for breakthrough therapy designation should not be submitted to pre-INDs, inactive INDs, or INDs that are on partial or complete clinical hold.
20) What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.
Note: For purposes of this webpage, all references to “drugs” include both human drugs and biological drug products regulated by CDER and CBER.
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Related Information
Fact Sheet: Breakthrough Therapies
Fact Sheet: Breakthrough Therapies
http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htmSHARE
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On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation. A breakthrough therapy is a drug:
intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
Please refer to section 902 of FDASIA for more specific information about this provision. Additionally, a Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics was published on May 30, 2014, providing a single resource for information on FDA’s policies and procedures as well as threshold criteria generally applicable to conclude that a drug is a candidate for one or more of the expedited development and review programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. .
Contact Information:
Center for Drug Evaluation and Research (CDER)
If your application is reviewed in CDER the CDER Breakthrough Therapy Program Manager is:
Miranda Raggio, RN, BSN, MA
Phone: 301-796-0700
Email: ondeio@fda.hhs.gov
Center for Biologics Evaluation and Research (CBER)
If your application is reviewed in CBER, for Breakthrough Therapy Designation information contact:
Christopher Joneckis, Ph.D., Acting Associate Director for Review Management
Phone: 240-402-8083
Email: Christopher.Joneckis@fda.hhs.gov
Related Information
Frequently Asked Questions: Breakthrough Therapies
No short funny business till it breaks out, accumulating between $0.60 -$0.45.
Great georgejjl, Then we can expect an update of Part B at 12, 26, 38, and 52 weeks. Does that sound correct? If true, we get some juice in Dec.
?
14 patients were in 12th week by the time of CTAD this should put the next update Jan Feb.
The critics will be drowned by those simple facts!
It's a beautiful thing!
Graphs of A2-73 Effect by Piotr Pietrzkiewicz
@PiotrPietrzkiew
https://twitter.com/piotrpietrzkiew
https://pbs.twimg.com/media/CTelu1cWsAA19YZ.jpg
https://pbs.twimg.com/media/CTV7LA-UcAAcNLo.jpg
https://pbs.twimg.com/media/CSIj6zhU8AAKs75.jpg
https://pbs.twimg.com/media/CSIjnuHUwAA4iBC.jpg
Improvement of Regression over Baseline
I do not know if this Comment By User 36926276 A2-73 and Improvement of Regression over Baselineon Seeking Alpha has been posted here, forgive if it has.
Anavex Life Sciences: Interview With Dr. Stephen Macfarlane
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
Her/His point measuring Regression from Baseline and Improvement Over Baseline: Comparing ACDS-ADL of Axon+DZP, DZP alone and A2-73 REGRESSION from Baseline.
The Astonishing Results: A2-73 Improvement (Raise) Over Baseline
SOC: Axon+DZP, DZP Reduced (slowed)Regression from Baseline
I wish that someone would stress the ACDS-ADL; though we realize it is not 'Stat Sig' YET it is quite significant for a few reasons:
1) Neither Donepezil or Axon have shown the ability to improve ACDS-ADL (Activities of Daily Living ie. every day quality of life capabilities) over baseline. Both have shown statistical significance in reducing the REGRESSION from baseline, DZP over no treatments and Axon+DZP over DZP alone but make no mistake about it patients still REGRESSED over baseline (patients ADL scores prior to starting the drug). This means that for the most part the benefit was 'phyric' in that patients and loved ones got to hear that 'it could have been worse' while experiencing regression in ADL every day.
The fact they show stat sig in reducing regression ALSO means they show stat sig to NOT improve ACDS-ADL over baseline
2-73 IMPROVED ACDS-ADL from baseline in 11 of the first 14 patients EVER to reach the very first milestone, 5 weeks. While that patient pool might not be enough to show stat sig, it is quite quite significant. If SOC and the 'leading candidate' already proved an't improve ADL over baseline even after 6 months and 2-73 does so in 80% of patients in 5 WEEKS then 2-73 is clearly on to something. 11 of 14 patients would have had to ALL experienced something no untreated or DPZ or DPZ-Axon groups ever did; improvement. You can jump all over 'not stat sig' all you want it is tremendously 'sig'. If those #s repeat in the remaining 18 patients as they reach week 5 and are even close to linear improvements by week 12, 2-72 will be well on it's way to proving it is the ONLY AZL drug that can IMPROVE the all important ADL for patients.
This should not be and should not have been understated; sure mention it is not yet stat sig but it is a hairs-breadth from being so even on a small sample size in a short time frame.
2) The P300, which as Avanex pointed out is indicative of other metrics, was almost 4x DPZ at 5 weeks and even better than DPZ was at 6 months. Again not stat sig but highly sig.
3) The MMSE was as good at 5 weeks as DPZ was at 3 months. Again not stat sig but highly sig.
Avanex has every right to communicate those REMARKABLE and promising achievements and did so in a highly responsible manner, reminding people that (simply because of sample size) the results were not yet 'stat sig' and that this was only a safety/tolerability trial (which they passed with flying colors). People who don't understand significance (or don't want to for their own agenda) don't understand that something can be quite *significant* before it is definitively STATISTICALLY so.
Finaly MACD, STO, RSI, on Daily Chart Oversold.
Edny Inui tweeted; "14 pts have reached wk 12 of part B"
so we can plugin what we know will be the time line: 12, 26, 38, 52.
She did a sloppy job of reporting on AVXL at the CTAD2015, she failed to point out Sat Sig was not designed into the trail, further spreading confusion
Edny Inui @BMTEdny Nov 7
$AVXL ANAVEX2-73 14 pts have reached wk 12 of part B; primarily reporting part A today #ctad2015
NEWS FLASH This is why A 2-73 will be Approved Nothing else is this EFFICACIOUS! Buy-um cheap while they last.
http://www.twitlonger.com/show/n_1snqu4u
Donepezil = Standard A2-73= Better !Wake Up Market
Yes, A2-73's improvement in this metric is not statistically significant when *compared to its baseline*; however, if you were compare it to donepezil, the current standard of treatment (black line in competitor, Axovant's figure), it quite probably would be with a larger sample (which will be available in a year at the end of the 52-week extension).
On daily the Chart needs restoration to be Bulish; Sto still not Over Sold, MACD Still Neg, RSI below 50
For a scientist to say this ....you know his busting at the seams to use hyperbole.
"We are encouraged by the preliminary safety and efficacy data.
To me this hints that A 2-73 is so efficacious that FDA my have to allow expansion of the trail because it would be unethical to deny its use the suffering who have no better alternative.
The PR was Magnificent and Clinical results (catalyst) will be coming quicker on this drug then most.
"We are encouraged by the preliminary safety and efficacy data. We look forward to continuing with PART B of the Phase 2a trial and expect to provide data updates at 12 week, 26 week, 38 week and 52 week time points," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "While we remain focused on Alzheimer's, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames."