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

  • 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...

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

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

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

  • 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...

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

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

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

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

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

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

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

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

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

  • $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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • 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...

  • 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...

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

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

  • 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...

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

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

  • 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...

  • 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. ...

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

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

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

  • 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...

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

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

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

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

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

  • 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...

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

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

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

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

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

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

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

  • 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 ...

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

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

  • $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 ...

  • $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 ...

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

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

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

  • 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, ...

  • " 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...

  • 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...

  • If I'm being honest, I was a little disappointed that he mentioned they will start it this month, and that they have not...

  • JohnM

    At the LD Micro Conference this morning, Norchi said they will start the sensitivity study in June, complete in three mo...

  • $apto It seems to me many people are in APTO based on APTO- 253 being approved by FDA for lab testing,,,,,,,,,,,( BIOP...

  • I think we just have to be patient and believe that the truth will be recognized. Surely, we've been slapped around by t...

  • LongOnLife

    Another smack to the chin. The CRL for the IV version of Meloxicam that $REPH has been developing was a surprise. The dr...

  • $REPH, $TTOO Good morning folks-- So a week or so ago, the FDA unexpectently issued a CRL for Recro's IV pain drug...

  • $arth Gaps are filled 91.4% of the time. $.70 is the target gap. Believe the price is in the process of discounting ...

  • Well, first of all, CBD is legal in all 50 states, although in Utah you need a prescription for it. If you want CBD wit...

  • Arth OW, nice to see stock price climb back over .40 again..Hopefully get back to it's old highs and beyond on FDA appro...

  • Hi Travis, Sesen Bio (SESN) formerly (EBIO) just announced Phase 3 results of a non-muscle invasive bladder cancer drug...

  • JohnM

    hipockts, I think you are being much too negative about ARTH management. (I am very OW.) 1. They did explain why they d...

  • May 10, 2018 -- APTO released a 23 page Q1 2018 Financial Report . The pdf file can be downloaded from http://phx.cor...

  • JohnM

    finventurer, if ARTH begins the three-month study on skin sensitivity to settle the only remaining outstanding issue for...

  • Gr8Full!

    $AKAO np > Achaogen Reports First Quarter 2018 Financial Results and Provides Corporate Update -- FDA Advisory Committe...

  • This site and Stock Gumshoe publications and authors do not offer individual financial, investment, medical or other advice. Nothing on this site should ever be considered to be personal advice, research or an invitation to buy or sell any securities. We also make mistakes and bad decisions sometimes, and our reasoning or data should be checked against trusted sources before they inform your investing decisions. Choices regarding how to invest your money or otherwise manage your life or finances are yours, we share only our analysis and opinion and all authors or commenters are individually responsible for the words and opinions they share here. Please read our important disclaimers and policies. Stock Gumshoe is supported by subscribers and by sponsors and advertisers. Stock Gumshoe's employee authors will disclose holdings in any stock covered at time of publication and will not trade in any stocks written about for at least three days after publication. Please see below for complete disclosure, disclaimer and policy information.

    Connect with Travis

    website designed by Gravity Switch