Topic Archives: FDA

Miracles Redux

The last time Dr Al Sears crossed our path, his banner headline was that President Obama, “the most corrupt president in U. S. history,” issued a “Death Order” in 2016 that “could result in the needless deaths of 1.3 million American seniors this year.”   That “Death Order” consisted in the appointment of Robert Califf, […]

“One tiny drug company … we think is the ‘surest thing’ we’ve ever found…” (Money Map Passport Club Teaser)

“Why I’m Ready to Place a $2,450 “Bet” on Your Behalf… “Given what we’ve learned about one tiny drug company – and the documented 82% success rate within the category of drug it’s developed – we think this is the “surest thing” we’ve ever found… “How this ‘wager’ could make you thousands of dollars (or […]

Comments

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    Please don’t spew your ignorant comments on here. Your negativity on medical imaging is harmful to the community. Fact...

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    JAMA...another highly tainted and untrustworthy entity, along with the FDA and CDC, designed to assist Big Pharma in mai...

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    Hello, hitman, I'm just getting started, only own 7 stocks. Was looking over your list, looking for validation I guess....

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    Fluorine is a known neurotoxin as well as a bone toxin and is linked to osteosarcoma. Teeth are made of hydroxyapatite,...

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    Your proposed actions are a violation the Nurenburg Code of 1948 to which the USA is signatory. Since no vaccine has e...

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    There was an interesting show on ABC 20/20 Friday 3/16/2019 about Elizabeth Holmes and her company, Theranos. She suppos...

  • Travis Johnson, Stock Gumshoe

    Not quite, but it’s usually an easier path than the typical drug approval process. Diagnostic tests have to be FDA ap...

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    I'd like to point out that since they are not developing a treatment or therapy, they are immune to the lengthy and trap...

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    This is what I have found about their latest Phase 3 trial: "The BETonMACE trial is currently expected to be completed w...

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    Travis, hi! Excellent work and i appreciate Gumshoe intellectual efforts. in the background, some fake news edited by b...

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    Big Pharma will squash any cure for cancer. They depend on people getting cancer to keep the money flowing. Big Pharma...

  • Gr8Full!

    Does your brain require stimulating? FDA Events Can Send Stocks Soaring: https://finance.yahoo.com/news/fda-events-sen...

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    As a grower and processor of hemp for CBD in Colorado, I can attest to the efficacy of high quality full spectrum CBD f...

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    I’ve always found the expression “Clinical stage” confusing for the description of biotech companies performing R&...

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    An orphan drug is defined as one with fewer than 200,000 people with the "disease". If this imaging agent will "treat" 8...

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    Hello Travis, I too was curious about the FDA approval drug, so I dug into it also. You have verified the same info that...

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    Well then Matthew McCall its pitching the same company with his Blockbuster FDA Approval Summit 2019 something that it's...

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    agree, this stock has been ho-hum at best. Was expecting a lot more bounce once FDA approval....quite disappointed actua...

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    What you need to realize is that they have raised money twice in the last year and a half - or whatever the timeline is....

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    Ok! FDA has now approved AC5 so where is the jump in stock price? Am I being impatient? What should realistic expectatio...

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    Keep the faith. The process has taken a lot longer then the initial excitement by some were hoping for. But the fact AC5...

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    $ARTH Long and OW - not to toot my own horn, but I believe I predicted a 14 or 17 Dec decision from that wonderful gover...

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    $ARTH FDA clearance - https://ir.archtherapeutics.com/all-sec-filings/content/0001144204-18-064761/tv509257_8k.htm...

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    $ZFGN long And if you're wondering why the share price plummeted today. https://www.fool.com/investing/2018/11/26/why-...

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    2018 Turkey. I agree that APRI was probably a 20 pound Bird in the roasting pan. When FDA didn't sign off, it HIT THE ...

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    #CRMD no position, but interested. Their trial for their medical device was stopped by the FDA back in the summer for...

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    $ARTH - Arch Therapeutics to Provide Corporate Update at the 11th Annual LD Micro Main Event on Tuesday, December 4,...

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    You gave a strange date range, "Let’s take a look at the remarkably large number of new cancer therapeutics that obtai...

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    Great Article! Thanks Doc Gumshoe. The problems of big pharma did not arise overnight anymore than somebodies arteri...

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    If something really works, the FDA will either find a way to make it illegal or just not available unless it comes from ...

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    $ARTH atlas long possibly approx 60 more days to go, right? and probably even longer since apparently FDA hasn't been...

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    $ARTH - also long. Interesting question. I don't think we will know till it happens. And it will happen. But the stock ...

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    Long term holder - what is everyone's expectations on stock price once Arth gets FDA approval? What about on announcem...

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    Did you actually read this report? Take an anatomy & physiology class, and / or a cell biology class, and get a gli...

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    Travis ,isn't it amazing how people get away with "stealing" other peoples' researched ideas and passing it off as their...

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    Another "cover-up" of natural cures? After sitting through most of their video presentation, I opted for their book and ...

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    I just saw that there is a class action lawsuit filed today against Namaste. It says the company made false and mislead...

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    I bought my shares through Interactive Brokers. I do not recommend IB their software is the product of programmers gone ...

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    You are correct the FDA has up to 90 days to respond. Arch Therapeutics now has a person on board to deal with submissio...

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    I believe that the FDA has 90 calendar days from the submission date of the 510K to respond. So that means we should he...

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    I think we need to listen to his presentation tomorrow for an updated to that. We have been here already what more does ...

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    $ARTH - Arch Therapeutics Announces 510(k) Submission to the U.S. FDA for AC5™ Topical Gel https://ir.archthera...

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    Joined the service when it was launched. I spend a lot of time with the FDA trader recommendations. But it has payed ...

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    Hi Cleveland, Do you think 510k will be (hopefully) approved closer to 90 days as application was already submitted onc...

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    If 510K is submitted soon, hopefully already has been. Does the 90 day FDA clock start again or should it be quicker? Re...

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    $ARTH - Arch Therapeutics to Provide Corporate Update at the Ladenburg Thalmann 2018 Healthcare Conference on Tuesda...

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    I read the results of the Phase 3 trials and they failed to meet expectations by a sizeable margin, so the stock, Proge...

  • Michael Jorrin,

    I am always pleased and entertained to see the variety of comments in reponse to my contributions to Gumshoe World. At...

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    Agreed. Team A brings the solution to FDA approval, TeamB comes in 'after' approval to minimize cash burn... e.g. after...

  • drbonz

    I wish I had your patience BnG. I understand mistakes can and will be made, but the ones ARTH has been guilty of, seem t...

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    Cleveland: Assuming $ARTH gets thru 3rd trial and FDA approval, can you share your thoughts on their go-to-market strat...

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    Thank you Cleveland the numbers bespeak your experience. Considering what has transpired with this stock with this si...

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    So the Big Parma influenced FDA is going to cut the throat of the medical mafia, which is almost 20% of our GDP, by sanc...

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    I too am interested in what Ray Blanco, FDA Trader, is talking about. A big announcement on Wed., Sept. 5 about how a D...

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    And the diseases they are targeting are much more able to have a conclusion in a clinical trial. If it doesn't cure the ...

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    nicotinamide adenine dinucleotide(NAD) $CDXC$ ChromaDex Corporation thought to combat age related diseases using Nico...

  • Travis Johnson, Stock Gumshoe

    Why would it appear that way? We're just going by the promises in the ad, which builds this "you'll make a fortune" pr...

  • LongOnLife

    It makes one wonder if there isn't more to it, in the current administration, than proving the drug works using the guid...

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    So much EMF we will soon be exposed to in terms of the broad rollout of G5 that a major health crisis may be in order. ...

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    As far as lsdyf they got a little bump in revenue about 200k from the canna strips which are flavored strips for breath...

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    Right. that's why, I think, one has to look at the current valuation of clinical-stage biotechs with a very critical eye...

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    I've been rethinking the underlying thesis of investing in clinical stage biotechs. The overarching idea is that the sci...

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    Hi backoffice, Let me give you my best guess on the 5 companies touted by Tremblay's Bio Insider Alert. I am quoting br...

  • Gr8Full!

    FDA to end Orphan designation for pediatric subpopulations...will close loopholes that allow drug companies to avoid con...

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    $AKAO Hey folks. Today Achaogen announced a major restructuring, laying off 28% of employees, as well as the coming d...

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    In 1988 the first report showing that ham radio operators had a much higher incidence of leukemia than the public was pu...

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    It just refering to mostly the well established bio tech marijuana stocks now that gw phar has a cannabis based product ...

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    In its May press release announcing its phase 3 trial result of its cholesterol-lowering drug, Esperion had to admit tha...

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    into phase 2 soon after clearance from hc and fda. patient 5 totally cancer free after 180 days. trial one only needed...

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    the above comment is dead wrong. TLT patient #5 no cancer after 180 days. got clearance HC and FDA for phase 2 after s...

  • Gr8Full!

    $MBRX Moleculin Expects to Meet FDA IND Filing Requirements for its Pancreatic Cancer Drug Candidate with Development Wo...

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    Thank you. That was the most comprehensive and clearest description on osteoporosis I've seen. A couple of questions...

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    What $1 pot Stock is Jimmy Mengel referring to that is being evaluated by the FDA for approval. Why are these guys so ...

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    7/2/18 $APTO (FP) -- SEC FILING giving more details about FDA lifting the clinical hold on APTO-253: "....a root...

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    6/29/18 $APTO Press release "FDA Lifts Clinical Hold so MYC Inhibitor APTO-253 Can Return to Phase 1b Trial In Pat...

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    If the current raise is enough to carry them through until their next FDA submission....

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    aahhhh, maybe that is where I first saw GWPH, from Hillary Kramer; thanks StockMidas. Today June 25 the US FDA approved...

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    Opioid FDA approval is granted to a private company called US world Med. Their product is going to be available this ye...

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    Asking for evidence that a potential new treatment cures (or at least causes remission) is laughable. It is only the FD...

  • JohnM

    Glad to, billy. Norchi lined up all the people needed for the sensitivity test, got them enrolled, and started the test ...

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    I'd like to discuss $CLRB, but perhaps we could take it to a different thread? regarding $ARTH, to be honest, I don't...

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    $CYDY np Does anyone still follow a story of CytoDyn? They have reached a primary endpoint in their phase2b/3 study on ...

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    $ARTH (fp) - Thanks for the update Cleveland, I appreciate your technical and financial analysis you provide. I believ...

  • JohnM

    $ARTH long. In addition to the two-week turnaround to get the 510(k) filed by the end of September, Norchi committed to ...

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    $PTN Hi Allison-- I don't know how valuable my insight might be; I'm not nearly an expert on this stuff, and while...

  • Gr8Full!

    $MBRX wow Moleculin Targets accelerated FDA approval of WP1732; Pursues Development for Ocular Tumors Click here to ...

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    $APTO Re my earlier post I see (hear) from the audio of Aptose' webcast of 1oth May that the necessary data had by that ...

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    Even if "Broadcast Power" (synonymous term for Nanoelectricity) were to be approved by all the agencies in the US - the ...

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    $APTO hello, is anyone keeping tabs on the position re the clinical hold? Over the last couple of days I've seen various...

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    Has anyone looked at BICX. They claim to have a novel way of providing medication for an extended time period 1 1/2 mont...

  • Gr8Full!

    $CLRB FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Rhabdomyosa...

  • Gr8Full!

    $CLRB and CLRBZ wow! > FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatme...

  • Gr8Full!

    $CLRB FDA Grants Rare Pediatric Disease Designation to CLR 131 for the Treatment of Rhabdomyosarcoma THX ODI! https://t...

  • JohnM

    You are right. As soon as Norchi realized the CE Mark would be delayed, he split the planned FDA filing into two parts, ...

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    " I don’t know why it has taken the manufacturer so long to complete the right paperwork, but my guess is that it requ...

  • JohnM

    No, the CE Mark is a safety approval that is much easier to get - you don't even have to do a clinical trial. (But you h...

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    That's a great point John, I didn't take that into account. One would hope if all aspects of the application are the sam...

  • JohnM

    The trial is 90 days long. I am talking about the length of time the FDA will review the refiled 510(k) application befo...

  • JohnM

    Because this was the only issue the FDA had and because they have approved the study design, I expect a positive outcome...

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