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  #276  
Old 07-13-2017, 09:25 AM
Bozzie Bozzie is offline
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Then again i have a plan to sell a small amount if it moves up before September.
I feel a little trapped in this right at this point.

I don't know fellas i'm calling this a toss up, Just too little info to look at it any other way.
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  #277  
Old 07-24-2017, 12:29 PM
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Looks like great news today!! Moving forward quietly, I like that.
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  #278  
Old 07-24-2017, 12:59 PM
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Looks like great news today!! Moving forward quietly, I like that.
great news.. now i can sell a little hopefully
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  #279  
Old 07-25-2017, 03:09 AM
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Why would you want to sell at this point? Isn't this slowly moving in the right direction?
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  #280  
Old 07-25-2017, 07:56 AM
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Why would you want to sell at this point? Isn't this slowly moving in the right direction?
i think the risk is high and i own a ton.. I bought some a while back with the intention of selling.
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  #281  
Old 07-31-2017, 01:14 PM
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I found this article:

More than 100 randomized clinical trials have been conducted in the hopes of finding a safe and effective treatment for sepsis. In 2011, Eli Lilly (NYSE:LLY) withdrew its previously approved sepsis drug, Xigris, from all markets after the drug, approved a decade previously with a statistically significant efficacy of 6%, failed to replicate the same result in a clinical trial of 1,696 patients.
Recently Spectral Medical, Inc. (OTCPK:EDTXF), a small Canadian company, released trial results for its sepsis treatment (EAA and PMX). While this treatment is not a drug, but a medical device, the same standard of proof for efficacy still applies: a statistically significant mortality benefit at 28 days.
Spectral’s trial, called the EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock), studied severe sepsis patients with septic shock, meeting the trial criteria of endotoxin activity assay (EAA) measurement ≥0.6, and a multiple organ dysfunction score (MODS) > 9 (which translates as having three organ failures). While the trial was powered to show a 20% efficacy in the per protocol group, it only reported 5%, which did not achieve statistical significance.
In a post hoc analysis of the trial data, some subgroups were shown to have achieved a better mortality benefit: 10.7% in patients with 0.6 ≤ EAA < 0.9 (n=194); and 21% in patients where no bacteria could be identified by culture (n=59). However, it is important to note that neither of these numbers are statistically significant according to the pre-approved statistical analysis plan (which requires 360 patients to show a statistically significant 15% benefit and approximately 1,200 patients to show a statistically significant 7.5% benefit).
In its post hoc analysis, the company claims that by using the data from a "modified" per protocol group, not the original, which excludes patients with EAA>0.9 and under a "modified" statistical method (when "baseline APACHE and mean arterial pressure were controlled in each arm"), these mortality benefits become "statistically significant." Considering the fact that sepsis is perhaps one of the most studied unmet medical needs, it is very doubtful that both these post hoc modifications are valid ways to establish the required statistical significance.
Over 1 billion dollars (US) have been spent on sepsis trials over the past decades to find a treatment and none have succeeded, except for Eli Lilly’s Xigris mentioned above. It defies logic that no company over the past decades, which, having conducted a large (thus costly) sepsis trial, would not have done what Spectral now proposes to do. For example, why would Eli Lilly attempt a large study of 1,696 patients to prove a 6% efficacy when a mere 194 patients can be sufficient to prove a statistically significant 10% according to Spectral Medical, Inc.? Indeed, if it is possible to simply modify the per protocol group as well as the statistical method post hoc to show a "better" trial result, the failure rate of over 90% in phase 3 drug trials could be greatly reduced.
Perhaps more importantly, the post hoc analysis of the trial result did not identify any possible cause for the much-lower-than-expected efficacy. Only 59 out of 244 patients had the expected 20% efficacy, and the PMX treatment did not work effectively in the remaining 185 target patients (the majority). Nor did post hoc analysis offer any significant steps by which the trial protocol might be improved (i.e. to show a better efficacy) besides a possible amendment in the protocol to exclude patients with EAA>0.9 (n=50, in which the PMX group has a higher mortality rate than the sham group). It is of note that the adverse effect on mortality in this n=50 subgroup was not addressed by Spectral’s team.
The variable which defined the best responding sub-group (i.e. n=59) within the trial is not useful in that this cannot be used as an additional selection criteria. For example, a culture to identify those sepsis patients who have no bacteria will most likely take longer than 24 hours. This further delay will no doubt adversely interfere with one very significant known factor in PMX treatment, namely that of "early" intervention. Indeed, the successful PMX trials that were done without the EAA assay as a selection criteria, unlike the EUPHRATES trial, stressed early intervention. Therefore, in reality, it will be impossible to identify which patients fall into this subgroup.
In his article on sepsis, Prof. Jean-Louis Vincent states that there are 170 biomarkers that have been proposed and assessed clinically in relation to sepsis. Given the complexities and the heterogenous nature of sepsis patients, Prof. Vincent states, "I do not believe that a single marker will ever be of use alone." Here perhaps lies the greatest limitation of Spectral’s trial and treatment: it is a protocol and a treatment of a single marker namely endotoxin. The EAA assay is all about measuring endotoxin level, and PMX is all about removing endotoxin.
In Japan, where the PMX treatment has been approved since 1994, the national sepsis guidelines state that endotoxin does not play a key role in sepsis pathology and therefore the effectiveness of a treatment such as PMX that removes only endotoxin as its mechanism of action is doubtful. In another review article about extracorporeal blood purification for sepsis, the authors similarly doubt the usefulness of these techniques, stating that "in severe sepsis, source control, early appropriate antibiotics, and haemodynamic support are the three most important treatment components." Simply put, the PMX treatment is removing only one of many biomarkers, which does not play a central or critical role in treating sepsis. In their conclusion on the use of blood purification techniques which includes PMX, the committee which works on the Surviving Sepsis Campaign, a committee which includes the principal investigator for the EUPHRATES trial, Dr. Phillip Dellinger, states (Section K): ‘In consideration of all these limitations, our confidence in the evidence is very low either in favor of or against blood purification techniques; therefore, we do not provide a recommendation. Further research is needed to clarify the clinical benefit of blood purification techniques.’ Finally, in a July 2017 Journal of Intensive Care, Letter to the Editor, commenting on the EUPHRATES trial results, the authors rightly concluded that "since this favorable effect was obtained from 'post hoc' analysis, further study is expected."
In conclusion, the EUPHRATES trial failed to meet its primary end point, and therefore the efficacy of the PMX treatment protocol using EAA assay as a patient selection tool remains unproven. There is no precedent for the FDA approving a treatment for sepsis, be it a drug or a medical device, that has no proven efficacy according to a statistically significant mortality benefit at 28 days.

What are your thoughts? This guy sounds like he knows what's going on.
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  #282  
Old 07-31-2017, 03:58 PM
tigerman19 tigerman19 is offline
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I read last week when it dropped one day. Went back up next day. That's actually a woman's opinions. Her and her husband are biotechs with PhD's. She said they invest in biotech. She did say they don't have an opinion on spectral.
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  #283  
Old 08-15-2017, 11:20 AM
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Succinct little report.
I like it.

Read the disclosure at the bottom as well.


https://gmpsecurities.bluematrix.com...om&source=mail
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Last edited by Bozzie; 08-15-2017 at 11:21 AM.
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  #284  
Old 08-15-2017, 12:45 PM
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Been several other articles out basically saying approval is dead.
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  #285  
Old 08-15-2017, 01:37 PM
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The Seeking Alpha opinion?
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  #286  
Old 08-23-2017, 12:58 AM
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Sorry so long. Yes, I believe it was that one.
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  #287  
Old 09-19-2017, 06:11 PM
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Anyone know what's up with this company? Any important dates coming up?
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  #288  
Old 09-22-2017, 01:29 PM
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Nice jump today. There was an announcement yest.
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  #289  
Old 09-22-2017, 09:17 PM
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Sounds like the FDA and Spectral are talking a lot.. end of the third quarter sounds like something is going to happen between the two.
i'm looking forward to the upcoming medical publication going to print.

Either way this is coming to a conclusion soon.
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  #290  
Old 09-25-2017, 03:20 PM
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Those gains didn't last very long...
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  #291  
Old 09-25-2017, 07:19 PM
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Block of 30K at the end of the day ate them up..
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  #292  
Old 10-30-2017, 09:53 AM
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Any update with this company?
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  #293  
Old 10-31-2017, 03:30 PM
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Getting closer to the final FDA decision....
Should be done by the end of January



Spectral Provides Update on FDA Meeting Regarding Its PMA Submission for Toraymyxin(TM)
TORONTO, ONTARIO--(Marketwired - Oct. 31, 2017) - Spectral Medical Inc., (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock, today announced the results of its recent meeting with the United States Food and Drug Administration ("FDA") concerning the status of its PMA application for Toraymyxin™.

The meeting consisted of a general discussion of issues identified by the FDA after the first 100 days of regulatory review and suggestions for clarification of those issues. The Company committed to a timely response to the FDA's questions, which is expected to occur during the month of November 2017.The next review cycle in the process is expected to begin after answers are provided by the Company and are deemed by the FDA to be complete. Generally, FDA guidelines suggest a 180-day anticipated timeframe for completion of review, excluding time required by the Company to satisfactorily respond to any issues.

"We had a productive discussion with the FDA review team, committed to answer the FDA's questions in a complete and expeditious manner and reaffirmed that we will work diligently with the FDA to address all aspects of their review. The Company remains focused on making a beneficial treatment for endotoxemic septic shock available for a specific group of patients where no other therapy exists", said Dr. Paul Walker, President and CEO of Spectral.
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  #294  
Old 11-14-2017, 01:39 AM
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If you're into the science behind EDT check this out.
it's a pretty compelling argument for approval.

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  #295  
Old 11-17-2017, 12:48 PM
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So you think someone is trying to dump 5-10,000 shares at a time?
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  #296  
Old 11-18-2017, 12:31 AM
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So you think someone is trying to dump 5-10,000 shares at a time?
Good point here
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  #297  
Old 11-28-2017, 12:19 PM
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anything interesting going on with this?
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  #298  
Old 12-18-2017, 08:39 AM
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Should be an up day



FDA Grants 510(k) Clearance for Spectral's Proprietary Stand-Alone Pump
TORONTO, ONTARIO--(Marketwired - Dec 18, 2017) - Spectral Medical Inc., (TSX:EDT), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced that the United States Food and Drug Administration ("FDA") has granted 510(k) clearance for the Spectral Apheresis Machine ("SAM") for use in continuous renal replacement therapy ("CRRT") and therapeutic plasma exchange ("TPE"). The Company has also submitted final documentation seeking approval of SAM from Health Canada and anticipates a decision in the first half of 2018.

SAM was initially developed with the intent of supporting the potential commercialization of Toraymyxin ™ ("PMX"), whereby intensive care units could use SAM to efficiently and safely deliver the PMX treatment to septic shock patients and not rely on third party CRRT machines. The regulatory path led the Company to first seek 510(k) clearance of SAM for CRRT applications, which has now been achieved. SAM has also been designed as an open platform hemoperfusion delivery device and the Company intends to seek further 510(k) clearance for this purpose when there is an FDA approved hemoperfusion cartridge available for use in the US market, including potentially Spectral's PMX treatment.

Because SAM was designed to be user friendly and to be built on a small footprint, the Company believes that there is an opportunity to pursue use of SAM in the broader CRRT market (not just potentially for PMX). The global CRRT market is projected to reach USD$1.5 billion in 2022, from approximately USD$1.1 billion in 2017. It is likely that any commercialization would be undertaken with a partner that has experience in these markets. The Company has exclusive license rights for SAM in North America for all CRRT applications and has worldwide exclusivity for any hemoperfusion applications.

"The 510(k) clearance for SAM has been achieved through extensive collaboration between the project management team at Spectral and the development team at Infomed SA in Geneva, Switzerland. We believe that SAM represents a landmark innovation in the CRRT field and we now plan to explore opportunities for the clinical deployment of this innovative patented technology, beginning initially with further testing of the instrumentation in hospital settings," said Dr. Gualtiero Guadagni, Vice President of Sales & Marketing at Spectral.

About Spectra l

Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with endotoxemic septic shock, Toraymyxin™ ('PMX"). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream.

PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 150,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 patients are diagnosed with severe sepsis and septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit Spectral Medical Inc. The first theranostic approach to Sepsis

Forward-looking statement

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

Spectral Medical Inc.
Anthony Businskas
Executive Vice President and CFO
416-626-3233 ext. 2200
[email protected]
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
[email protected]
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Last edited by Bozzie; 12-18-2017 at 08:41 AM.
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  #299  
Old 12-18-2017, 07:04 PM
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FDA stepping up on targeted therapies ..very good news for this stock.

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies
For Immediate Release
December 15, 2017
Statement
In recent years, the medical community has experienced a shift in the way health care is practiced. Rather than focusing solely on how to treat an overall disease type, medical innovators are now exploring how to tailor treatments that target unique characteristics of an individual’s disease, such as the genetic profile of a person's tumor. Innovation in this modern, targeted approach to medicine has already led to new more targeted medicines and, in some cases, therapies that are tailored to individual patients.
The FDA has an important role to play in advancing this targeted approach to treating disease by building a modern framework that ensures we’re providing the guidance and resources needed to efficiently develop these novel products using new technology. In particular, the FDA needs to clarify and expand an existing pathway that allows innovators to develop products based on the molecular markers that the drug targets, rather than the more traditional approach to drug development, where new medicines were developed based on the disease phenotype that they targeted. In many cases, science is revealing that the driver of disease is really a molecular change in the body. New drugs are being developed based solely on their ability to target these underlying molecular subtypes. Moreover, this same molecular change may be present as the driving factor of many different disease phenotypes. When drugs successfully target these molecular mistakes to reverse the effects of different diseases, we need a development pathway that allows the new drug to pursue approval in each of these novel settings on the basis of the molecular marker that the drug targets. In the setting of oncology, this is often referred to as tissue agnostic drug development.

By providing clear guidance on the regulatory and scientific frameworks for product developers, safe and effective targeted treatments can be identified with scientifically valid tests and ultimately, made available to patients faster. That’s why today we are issuing two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.

The first draft guidance, “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease,” addresses the important topic of finding treatments that address the underlying molecular changes (e.g., genetic mutations) that often cause or contribute to diseases, including uncommon molecular changes that are present in a small subset of patients. This draft guidance (which is also in a more concise, streamlined format) proposes an approach for drug developers to enroll patients based on the identification of rare mutations into clinical trials for targeted therapies when reasonable scientific evidence suggests the drug could be effective in patients with these genomic findings. The guidance discusses the evidence needed to demonstrate effectiveness for a variety of molecular subsets within a particular disease, which could lead to more consistent development and approval of targeted therapies for patients who are likely to benefit from them. These scientific principles described in the guidance could also be applied to supporting “tissue agnostic” drug development. This relates to how drugs may be able to gain regulatory approval on the basis of targeting a molecular subtype that is common across different phenotypes, rather than solely on the individual disease states. We think both approaches have the potential to increase the likelihood of finding viable treatment options for those with less common mutations. When finalized, this draft guidance will represent the FDA’s current thinking. The FDA also plans to publish a manuscript early next year that provides a detailed, comprehensive look at this issue.

The second draft guidance, “Investigational IVD Devices Used in Clinical Investigations of Therapeutic Products,” seeks to provide those running clinical trials with a clear framework to reference when determining if an in vitro diagnostic (IVD) device used in a therapeutic product study must undergo its own FDA review, distinct from the drug being studied. To develop new targeted therapies that are safe and effective, clinical trials often use investigational, or unapproved, IVDs to assess biomarkers and guide the selection of therapeutic products or care strategies that are applied to study participants.

When final, this draft guidance will clarify the appropriate regulatory pathway for investigational IVDs used in clinical trials for therapeutic products, which is significant so that trial results for a novel targeted therapy are not undermined just because the diagnostic test to determine a specific biomarker did not meet appropriate regulatory criteria. The aim is to make the process for developing more targeted “drug and diagnostics systems” more efficient and to simplify the proper development of these approaches.

Building on the IVD draft guidance issued today, we are also considering ways to streamline the review of oncology therapeutic products and the IVDs used with these products, and plan to issue draft guidance on this in the near future. The goal is to reduce the burden on sponsors for the development of certain cancer drugs, and on FDA staff as well.

These draft guidances are just a few examples of the FDA’s ongoing efforts to advance the development of innovative, targeted drugs and foster the availability of individualized treatment approaches. For example, earlier this month, the FDA issued draft guidance that describes a potential new approach for companies to collaborate and test multiple drug products in the same clinical trials for rare pediatric diseases, thereby reducing the number of patients treated with placebo. We also outlined how modeling and simulation can be used to reduce the reliance on placebo arms in these rare pediatric settings. Finally, we specifically addressed a more efficient pathway for developing drugs targeted to the rare pediatric disorder Gaucher Disease. We also recently authorized three, novel next generation sequencing-based devices for the detection of multiple cancer markers with the run of a single test – enabling the development of evidence to drive more individualized care management decisions.

By proposing streamlined approaches for our colleagues in the research and development communities, the FDA hopes to enable more efficient access to safe and effective, novel targeted therapies for the patients who need them. We look forward to receiving feedback on the draft guidances issued today and remain committed to assisting the medical community as it further modernizes and individualizes approaches to care, to increase the public health benefit offered by new medical technologies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Related Information
FDA Draft Guidance: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease (PDF - 75KB)
FDA Draft Guidance: Investigational IVD Devices Used in Clinical Investigations of Therapeutic Products (PDF - 731KB)
FDA Draft Guidance: Pediatric Rare Diseases: Collaborative Approach for Drug Development Using Gaucher Disease as Model (PDF - 262KB)
FDA: Companion Diagnostics
FDA: Investigational Device Exemption (IDE)
FDA: Investigational New Drug (IND) Application
FDA: CDRH Office of In Vitro Diagnostics and Radiological Health
FDA: Pharmacogenomics: Overview of the Genomics and Targeted Therapy Group
FDA: Oncology Center of Excellence
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  #300  
Old 12-27-2017, 11:04 AM
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If nothing else this is an insurance policy that we won't go to zero if this isn't approved.



FLXN Steers SHIP, NVAX To Report Data In Feb, FDA Nod For AERI, Spectral Shines - Nasdaq.com
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