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Get ready 510k with FDA fixing to be approved
Great post with real DD, I hope it is not like all penny stocks, but time will tell.... Thanks for the post....
and yet...
"(2) Based in part on information provided in a Form 4 filed on December 22, 2014. The shares beneficially owned by Lambda Investors may be deemed beneficially owned by Wexford Capital LP, which is the managing member of Lambda Investors, Wexford GP LLC, which is the General Partner of Wexford Capital LP, by Charles E. Davidson in his capacity as Chairman and managing member of Wexford Capital LP and by Joseph M. Jacobs in his capacity as President and managing member of Wexford Capital LP. The address of each of Lambda Investors LLC, Wexford Capital LP, Mr. Davidson and Mr. Jacobs is c/o Wexford Capital LP, 411 West Putnam Avenue, Greenwich, CT 06830. Each of Wexford Capital LP, Wexford GP LLC, Mr. Davidson and Mr. Jacobs disclaims beneficial ownership of the shares of Common Stock owned by Lambda Investors except, in the case of Mr. Davidson and Mr. Jacobs, to the extent of their respective interests in each member of Lambda Investors. Includes 11,742,100 shares issuable upon exercise of warrants held by Lambda Investors having an exercise price of $0.30 per share and 2,782,576 shares issuable upon exercise of warrants held by Lambda Investors having an exercise price of $0.40 per share. Lambda Investors is controlled by Wexford Capital LP. Arthur H. Amron, one of our directors, is a Partner and General Counsel of Wexford Capital LP. Paul A. Mieyal, one of our directors and former Acting President, Acting Chief Executive Officer, and Acting Chief Financial Officer until April 15, 2015, is a Vice President of Wexford Capital LP."
"The following table sets forth the beneficial ownership of our common stock as of June 30, 2015, by (i) each person known to us to own beneficially more than five percent (5%) of our common stock, based on such persons’ or entities’ filings with the SEC as of that date; (ii) each director and named executive officer; and (iii) all directors and executive officers as a group:
Name and Address of Beneficial Owner Amount and Nature of Beneficial Ownership Percentage of Class (1)
Lambda Investors LLC(2) 29,990,870 64.1 %"
Is this a share selling scam???
As with all pennystocks, time will tell...
They certainly have struggled...and had many problems with the FDA...
Including the FDA jerking them around for 15 MONTHS...
failing to even give them an ANSWER!
And the shareholders have suffered, while the officers pay themselves nice salaries...
again typical... LMAO
But I said a long time ago...I'll bail when Wexford/Lambda does...
and I'm sticking with that.
Lincoln Park is NOT the friend of any shareholder though...
just my opinion...of course....
I think the shareholders should be more concerned about this...
"All 5,150,000 shares registered in this offering which may be sold by us to Lincoln Park under the Purchase Agreement are expected to be freely tradable. It is anticipated that shares registered in this offering will be sold over a period of up to 36 months commencing on the date that the registration statement including this prospectus becomes effective. The sale by Lincoln Park of a significant amount of shares registered in this offering at any given time could cause the market price of our common stock to decline and to be highly volatile. Except with respect to the 250,000 shares of common stock already issued to Lincoln Park pursuant to the Purchase Agreement, Lincoln Park may ultimately purchase all, some or none of the 5,150,000 shares of common stock registered in this offering. If we sell these shares to Lincoln Park, Lincoln Park may sell all, some or none of such shares. Therefore, sales to Lincoln Park by us under the Purchase Agreement may result in substantial dilution to the interests of other holders of our common stock."
http://www.sec.gov/Archives/edgar/data/1196298/000114420415049019/v417876_s1.htm
Investigations Compliance Actions and Activities Warning Letters 2015
Nephros, Inc. 5/27/15
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969
WARNING LETTER
May 27, 2015
VIA UNITED PARCEL SERVICE
Nephros Inc.
Attention: Mr. John Houghton, President & CEO
41 Grand Avenue, Suite 201
River Edge, New Jersey 07661-1947
15-NWJ-05
Dear Mr. Houghton:
During an inspection of your firm located in River Edge, New Jersey, on October 08, 2014 through October 24, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices including, but not limited to: Dual Stage Ultrafilter (DSU); Single Stage Ultrafilter (SSU); OLpur H2H Hemodiafiltration System; and OLpur Mid-Dilution Series Heinodiafiltration System. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
The inspection revealed that the devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)] in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received your written responses, dated November 13, 2014 and December 11, 2014; and responses from Mr. Greg Collins, Vice President R&D, dated January 9, 2015 and January 22, 2015, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations, issued to your firm on October 24, 2014.
We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to document the evaluation of potential suppliers as required by 21 CFR 820.50(a)(1).
For example, your firm evaluated potential suppliers based on a designated supplier type related to the services and/or products provided. Review of your vendor list found that not all suppliers had questionnaires completed and/or a quality agreement in order that your firm is made aware of changes to products and/or services. Quality oversight of your suppliers will ensure that your firm is made aware of changes which may affect the quality of the finished device. Examples of active suppliers who had not been adequately evaluated included a supplier used for sterilization of your finished devices and suppliers of dialyzers and dialysis equipment.
It should also be noted that deficiencies in purchasing controls had also been observed during the previous inspection of your firm.
We reviewed your firm's responses and conclude that they are not adequate. We acknowledge that your firm created CAPA 13-014, dated 09/06/2014, and CAPA 14-030, dated 10/27/2014, which included the reduction of your approved supplier list to reflect only those vendors that are actually involved in the production of your medical devices. You also revised your SOP 7.4, Purchasing and Monitoring/Supplier Monitoring Controls, dated 01/08/2015, to more clearly define your supplier
types. You identified your contract manufacturer as being the responsible party for sterilization of your medical devices as they contract this service out, therefore, they were removed from the approved supplier list. Please be advised that as the owner and 510(k) holder of medical devices, your firm is responsible for oversight of all manufacturing operations and, therefore, has regulatory responsibility for the quality and safety of the medical devices that you market and distribute.
2. Failure to include required information in your records of complaint investigations as required by 21 CFR 820.198(e).
For example, your SOP 8.2.1, Customer Feedback, Complaint Handling & Monitoring, dated 01/23/2014, Section 9.5, states that the initial investigation shall be documented on the customer complaint form and, based on the nature of the complaint, must include: evaluation of the returned product or inventory retention samples; review of in-house device history records; review of shipping records; review of complaint trends; review of risk controls; and/or review of product labeling. Your complaint investigations were observed to be inadequate in that they were lacking critical information, as evidenced by the following customer complaints including, but not limited to:
a) #2014.01.01: Complaint involved the In-Line Dual Stage Ultrafilter (DSU) which had bacterial and endotoxin counts at the machine post filter. The investigation failed to include label reviews, inventory analysis, and trend analysis.
b) #2014.03.04: Complaint involved the In-Line Single Stage Ultrafilter (SSU) which had a filter leak around the spout. The investigation failed to include label reviews, inventory analysis, and trend analysis.
c) #2014.08.04: Complaint involved the OLpur H2H Hemodiafiltration Module Substitution Filter which failed an integrity test on the module. The investigation failed to include DHR review, inventory analysis, and trend analysis.
It should also be noted that deficiencies in complaint handling had also been observed during the previous inspection of your firm.
We reviewed your firm's responses and conclude that the adequacy of your responses cannot be determined at this time. Your responses stated that you initiated CAPA 14-020, dated October 26, 2014, and CAPA 14-029, dated 10/27/2014, in order to improve the complaint handling process. Your firm also revised SOP 8.2.1, Customer Feedback, Complaint Handling & Monitoring, dated 11/11/2014, and the Customer Feedback/Complaint Form F-8.2, which requires that there shall not be any unaddressed sections or blank fields on the complaint form. Additionally, your responses stated that you conducted a retrospective review of all 2013 and 2014 complaints to ensure forms were completed. Your response includes the complaint numbers reviewed, but failed to include the actual customer complaint files, in order to provide supporting evidence that your complaint files were updated. We will review your revised procedures and ensure that they are implemented in addition to verifying that all complaint files/investigations include critical information, during the next inspection.
FDA also noted nonconformances with section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)], which are deficiencies pertaining to the Medical Device Reporting (MDR) Regulation found at Title 21, Code of Federal Regulations (CFR), Part 803. These nonconformances include, but are not limited to, the following:
1. Failure to include the following information in your firm's reports, if known or reasonably known to your firm, as described in 21 CFR 803.50(b). This type of information corresponds generally to the format of FDA Form 3500A: "Date of event," (Form 3500A, Block 3B), as required by 21 CFR 803.52(b)(3).
Specifically, your firm submitted 33 MDRs to the FDA that did not identify the "Date of event" in Block B3 of the FDA Form 3500A. In addition, your firm did not include in Block H11- "Corrected data", of the associated 3500A forms, an explanation of why the required information was not provided and the steps taken to obtain such information.
We acknowledge that your response, dated November 13, 2014, states that you had submitted 33 supplemental MedWatch reports to CDRH's MDR Policy Branch on November 12, 2014. However, your response, dated December 11, 2014, is not adequate. Your firm submitted a revised MDR procedure titled" "US-MDR, EU-MVR, Canada-MPR, Advisory Notices & Recalls", SOP 806, Rev B, dated December 4, 2014. Although the revised procedure includes instructions for completing the FDA Form 3500A, the following additional issues need to be addressed:
(1) "US-MDR, EU-MVR, Canada-MPR, Advisory Notices & Recalls", SOP 806, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. The procedure omits the definition of the term "reasonably suggests," found in 21 CFR 803.20(c)(1). The exclusion of the definition for this term from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
(2) "US-MDR, EU-MVR, Canada-MPR, Advisory Notices & Recalls", SOP 806, does not establish internal systems that provide for timely transmission of complete medical device reports.
Specifically, the following is not-addressed:
a. The procedure does not include the address for where to submit MDR reports as follows: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
(3) "US-MDR, EU-MVR, Canada-MPR, Advisory Notices & Recalls", SOP 806, does not describe how your firm will address documentation and record-keeping requirements, including:
a. Documentation of adverse event related information maintained as MDR event files.
b. Information that was evaluated to determine if an event was reportable.
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this fmal rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
www.fda.gov/Forindustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
A follow up inspection will be required to assure that correction and/or corrective actions are adequate. Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in reguiatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised ofthe issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related.will not be approved until the violations have been corrected. Requests for Certificates to Foreign Government will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response to this letter should be sent to: U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, New Jersey 07054 (re: CMS #449134). If you have any questions about the contents of this letter, please contact Stephanie Durso, Compliance Officer, at 1-973-331-4911 (phone) or 1-973-331-4969 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list ofthe violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Sincerely yours,
/S/
Diana Amador-Toro
District Director
New Jersey District
2015
Page Last Updated: 06/01/2015
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You are wrong the correct date is 6/18
LMAO, right FDA shutting them down in near future....
I sniff out and short bogus companies but, this isn't one of them.
You Are Correct FDA Warning Letter 15 day reply time is up 6/16/15
CAN YOU SMELL IT BANKRUPTCY IS COMING
FDA WARNING LETTER
Think before you speak Ddls!!
Ddls,thanks for nothing!!!!
$113,000,000 Deficit Worse than snake oil
There is no truth in your post!!!!!
Small Company Offering and Sale of Securities Without Registration (
Date : 05/27/2015 @ 4:52PM
Source : Edgar (US Regulatory)
Stock : Nephros, Inc. (QB) (NEPH)
Quote : 0.68 -0.02 (-2.86%) @ 4:00PM
What the hell is this scam city
This stock is garbage. Snake oil even the govt doesn't want it
I am shorting this in the morning the FDA is fixing to shut them down
LMAO
However, failure to promptly address the issues raised in the Warning Letter to the FDA’s satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, delays in approval of any FDA applications, product seizures, injunctions and civil monetary penalties. Any such actions could disrupt our ongoing business and operations and potentially have a material adverse impact on our financial condition and operating results.
FDA is fixing to close NEPH down
However, failure to promptly address the issues raised in the Warning Letter to the FDA’s satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, delays in approval of any FDA applications, product seizures, injunctions and civil monetary penalties. Any such actions could disrupt our ongoing business and operations and potentially have a material adverse impact on our financial condition and operating results.
FDA Warning Letter (Better SELL this junk right now, FDA is going to shut them down)
On May 28, 2015, the Company received a warning letter dated May 27, 2015 (the “Warning Letter”), from the U.S. Food and Drug Administration (the “FDA”) resulting from an inspection of the Company’s facility in River Edge, New Jersey by the FDA’s New Jersey District Office that occurred during October 2014. The Warning Letter alleges deficiencies relating to the Company’s compliance with the Quality System regulation and the Medical Device Reporting regulation. The Company takes the matters identified in the Warning Letter seriously and is in the process of evaluating the corrective actions required to address the matters raised in the Warning Letter. The Company also is in the process of preparing a response to the Warning Letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA, and to work diligently and expeditiously to resolve the issues raised by the FDA. The Warning Letter does not restrict the manufacture, production or shipment of any of the Company’s products, nor require the withdrawal of any product from the marketplace. However, failure to promptly address the issues raised in the Warning Letter to the FDA’s satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, delays in approval of any FDA applications, product seizures, injunctions and civil monetary penalties. Any such actions could disrupt our ongoing business and operations and potentially have a material adverse impact on our financial condition and operating results. A copy of the Warning Letter is attached hereto as Exhibit 99.1.
snake oil value
Beware this is a pump and dump scam being run by the company and nothing but share selling scam, run as fast as you can and sell right now LMAOA
This is just the start "Home Skillet" to the road to trip 0000000 nothing but a scam, sell now...
There is no value to this stock or product, just another pump and dump scam.... Run sell now, listen it is going down in one month it will be trip0000000000000000 Sell now while you still can recover some of your money LMAO piece of junk stock nothing more...
We are going to make several "runs". It looks good from the last Q.
Yea you got in at 1.25$ right. Stay strong this will move to 5.00$ by summers end. (End sarcasm)
NEPH is struggling, to be sure...
but frankly, I blame a lot of it on the FDA.
Look back and see just how long it took to get that filter approved.
Time is money...and in this case, money LOST.
Years of "questions", followed by re-submissions, followed by more "questions"...and then the missed deadline for the response...
(sound familiar?)
Totally unbelievable, and inexcusable.
I hope to hell things work out better for G...
I've held on to both, through all this BS...
I certainly haven't done it because I expect to make a killing...
I believe in the tech...
Maybe some day the potential will be realized.
:)
Hi Dianne. After the long approval delays, the company only has been able to muster 1 3/4 million in revenues out of its lead product to sustain a stock price of .65. NEPH needs to have its filter business kick in bigtime, at some point, or things just aren't looking that good.
I am wondering if anyone is still active on this board. It looks like the last post is half a year old. I have just come across Nephros as an OTC stock, but I know that there are some developments that are not noted on his board. I am interested in some of the high points of the DD around here to see if taking a position makes sense.
All the best,
Silversmith
Seems like this company does about 2 rights offerings a year now...
and hey, that's fine...
better than using death spiral financers like others do.
But I hardly feel like their giving me a "discount" when the pps
always plummets to the rights offering price...
:(
Another great day today 12# Gain so nice this is under the radar .
What is the OS and the AS on this ticker ?
Yes this does look like a good one thanks again for the HOT TIP !! Funny what you can find when you read HISTORY .LMAO
Bought small position today it is looking like a good LONG TERM investment at this point will watch for a few days while I do more DD before buying larger stake. Any thoughts from the board on long term projections here .
Putting this one on my watch list need to do some DD before I take a position here .LMAO
Looks like this generated some interest...
I can see why.
IF the trial goes well, this could make a world of difference for NEPH!
About time...been here forever...
:)
I've stuck with this company because of it's government...let's
say associations, and now finally, the company could see a 100 x
expansion.
I sniff out and short bogus companies but, this isn't one of them.
ddls Member Level Tuesday, 08/27/13 02:55:53 PM
Re: shotcallers post# 1721
Post # of 1735
We are going to make several "runs". It looks good from the last Q.
Hi! It's been pretty quiet here :)
Did you participate in the rights offering?
I skipped it again.
Last time I kind of regretted it afterwards...
Looks like we might see the same bump this time around.
I bought a few shares to flip if that happens.
I still can't understand why these people aren't marketing their water filter to dooms day preppers/campers/etc.
Was glad to see:
"Legal Proceedings
There are no currently pending legal proceedings and, as far as we are aware, no governmental authority is contemplating any proceeding to which we are a party or to which any of our properties is subject."
Was a little worried after this:
"Nephros initiated this voluntary recall of these POU filters because the Food and Drug Administration (FDA) informed the company that promotional materials for these non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
In addition, Nephros has received reports from one customer of high bacterial counts that may be associated with the breakage of fiber in four filters. According to the reports received, one death and one infection may have occurred due to the failure mode associated with this voluntary recall. Investigation into these reports is ongoing. Prior to receiving the complaints mentioned previously, Nephros had received 29 additional complaints of high bacterial counts that may be associated with the breakage of filter fiber, since it began marketing the products. We have had no reports of adverse events associated with these 29 complaints."
:(
Getting interesting around these parts
This sure has been a bumpy ride!
I participated in the first rights offering,
didn't in the second...
Now we have yet a another rights offering!
I struggle with putting more money in
when I'm really having doubts about the company's ability
to deliver any return on investment to the shareholders.
:(
The recall is a problem.
What are your thoughts on this these days?
Are you going for the rights offering again?
Over subscribing again?
Wholly crap we got news
Good Grief! ANOTHER rights offering!?!
OMG...
Well, actually you can say all stocks are scam stocks, even the
cream of the cream. Why? Because the entire market is controlled by
about 12 of the richest people in the world, with the USA's government
assistants.
To be perfectly honest with you, this stock is getting hammered by
naked shorts with lots of money to do it. Why? Because NEPH is taking
profits from the big kid on the block. They have the money to stop
the erosion.
I hope this is not another scam stock
We are going to make several "runs". It looks good from the last Q.
Look at TJ'S history and you'll see the problem.
He probably didn't even look at the latest Q report.
WHY THE HELL ISN'T THIS COMPANY MARKETING THEIR FILTERS TO THE PUBLIC???
Think campers, doomsday preppers, etc.
The filter they are trying to sell to the military is something similar to this:
"lifestraw"
http://www.vestergaard-frandsen.com/lifestraw/lifestraw
Neph's version:
http://www.nephros.com/uf-30l/
WTF!!! are these people so stupid they can't see the potential?
Ummm that's a load of crap, company well funded and that's a general statement.
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