Topic Archives: FDA

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, […]

[Ed note: Following is another installment from our favorite medical scribe, “Doc Gumshoe” (no, he’s not a doctor). We feature Michael’s commentary every couple weeks or so, and his thoughts and words are his own. “Doc” doesn’t pick stocks, but FDA decisions are a huge driver of investment success for pharmaceutical and biotech companies and […]

“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

  • For anyone not wanting to wait for FDA approval of psychedelic LSD therapy all they need to do is go Golden Gate Park ...

  • Psychedelics would be a far better alternative than the addictive psych drugs the big pharma drug dealers make such as ...

  • Nice even-handed summary. Google scholar has some reviews on efficacy of the treatments, most of which look "promising" ...

  • Growing up in the 1950s, there were over 400 students in our primary school. ZERO were obese. Two brothers were what w...

  • NVO has been a good investment over the years. Collect the dividends, albeit small, in the mean time until FDA approval...

  • Hi Roozie. I am copying and pasting this from another gumshoe member who posted this in another thread. It may naswer to...

  • PAR:ASX 8 November 2021 09:00am (AEDT) PAR: Global Market Research indicates price for Zilosul KEY HIGHLIGHTS • Glob...

  • PAR:ASX 8 November 2021 09:00am (AEDT) PAR: Global Market Research indicates price for Zilosul KEY HIGHLIGHTS • Glob...

  • PAR:ASX PARADIGM’s INVESTIGATIONAL NEW DRUG (IND) APPLICATION CLEARED BY THE US FDA. PHASE 3 STUDY IN KNEE OA CAN COMM...

  • Travis, you are spot on with this Jeff Siegel promotion ! According to my research December 9th should include the NEWS ...

  • is this not game changing? fda approval https://www.newswire.ca/news-releases/cognetivity-neurosciences-granted-fda-cle...

  • Recently, I took a shot on Unity Biotech (UBX) even though their trial one failed to revile significant results. There ...

  • At one time WHO and FDA were neutral bodies but not anymore FDA is run by big pharma who it is supposed to keep check on...

  • I’m somewhat at a loss as to how to respond to some of the very carefully written comments to the October 5th Doc Gums...

  • Well they already had a huge surge in March/April, and India's most populous state of Uttar Pradesh turned to ivermectin...

  • The FDA also approved Vioxx -- which was find until it became obvious that the drug had very serious side effects. Due ...

  • That is not true! These trusted companies provide us with only the safest and most effective drugs. They even ensure tha...

  • For clinical settings regulated by the FDA , you must have quantifiable results based on a specified amount of any given...

  • With FASUDIL being approved in China and Japan and costing about 460 Euros for a 10 pack on line, other than lacking F...

  • Psychedelics are well known to the FDA and Pharmaceutical companies. The VA hospitals have been using them to treat vet...

  • IMO, CYDY is a complete fraud - they have been declaring themselves the 'close to FDA submission for final approval of b...

  • VANCOUVER, Washington, Aug. 13, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY) (“CytoDyn” or the “Company”), a lat...

  • Thanks Doc for another great update. It's always refreshing to read fact-based analyses. Any thoughts about Regeneron'...

  • Please supply links to the successful treatment reports you quote, the scenario you describe paints the picture of a co...

  • Pot has medical benefits unlike legal alcohol and cigarettes. If you ever suffer from anxiety panic attacks or PTSD you...

  • Thanks doctor_bb. Would be curious if someone having access to PM's report can post here whether he has any updates as t...

  • Hi there ! Anyone tracking SENS and have insights into their 180 day monitoring system's FDA status. Whether they alread...

  • Ok, this might be silly, and I'm not recommending it to anyone else, but I just bought a little more at $1.97 after hour...

  • From Marketwatch: Shares in Ardelyx Inc. ARDX, +2.67% plummeted more than 70% in after-hours trading Monday, following t...

  • I looked at all the comments and noted that a promising treatment which has been in test at the University of Colorado,...

  • Compass (CMPS). Valuation: $1.4B. Pipeline: Pre-clinical to Phase 2(b) for Treatment Resitant (TRD). Molecule: Psilocybi...

  • Hey Everyone, I was talking with a friend of mine who is a physician at a drug treatment facility here in NY, she is the...

  • One thing that is clear is that the FDA is dysfunctional. It's questionable approval of aducanumab, combined with its...

  • In the meantime I learned that Jeff Brown 7 penny IPO's are small biotech companies that are already publicly traded. So...

  • What $ENZC is up against. Hmm.. “The FDA collects millions in user fees from pharmaceutical companies. The Dept. of T...

  • I have tried several of HSI's treatments and none worked for me.What is the deal with gilead sciences yescarta cancer tr...

  • $ENZC - JUNE MOON Possible Catalysts; 1️⃣ PR from Intel on Partnership 2️⃣ PR on FDA Fast-tracking animal studi...

  • In response to your piece on Pritumumab, a more effective treatment for brain cancers is antineoplastons. Dr Burzynski h...

  • Yes, these are tools to test your sugar levels but they do not solve the horrible problem of insulin needles that go to ...

  • just i want to warn all of you guys stay away from this James ALT*****, i lost 5000.00 for listening to him and @ the l...

  • Travis: Thank you for the head ups and analysis on Schrödinger (SDGR). It is a very interesting technology and company...

  • Conformis Gets FDA Clearance for Identity Imprint Knee Replacement System Mentioned: CFMS By Chris Wack Conformi...

  • Pretty much every tease uses that language, if they don’t have the urgency of a specific date they can come up with to...

  • Strange comment... I guess that you did not bother to look at the TauRx website. This is not "a guy", this is a real c...

  • I don't remember where I heard about it first but I think it is Aquabounty. AQB has patents for GMO salmon, it is FDA ...

  • Great read Travis. Thanks for all the effort(s) made to inform/educate. As for 'Traveling Salesmen' who promote magica...

  • $PAR:ASX IND submitted to FDA https://hotcopper.com.au/threads/ann-paradigm-delivers-ind-to-us-fda-for-pivotal-oa-progr...

  • @miguki- I sold half my shares. From my understanding the company is suppose to have an announcement. Maybe it will be a...

  • I normally do not pump stocks or anything but for all of you that must unfortunately monitor you sugar intake etc.... ...

  • Are you familiar with another mAb called leronlimab, it’s produced by a company called CytoDyn. Phase III trial data w...

  • What about inhaled interferon beta from UK company Synairgen (SNG). They are currently undergoing a global phase 3 trial...

  • Ampion, AMPE is a company working on FDA approval for their drug. Don’t think they’ve actually received FDA final ...

  • I know some of you are not happy with QDEL earnings call, and while we all wait for the holy grail of covid test however...

  • I see some of you are not happy with QDEL earnings call, however here's an alternative. Their CEO mentioned they are str...

  • $PAR:ASX Cap51's B & C Series Investor Note at end of Jan - I'm sure they won't mind me posting it. https://www.fiftyon...

  • Penumbra's catheter has an active recall on its catheter with the FDA as of today; This does not bode well for their ma...

  • Capricor Therapeutics Announces Positive Preclinical Data for Multivalent Exosome-mRNA Vaccine For COVID-19 November 09,...

  • CYDY about to explode like a volcano!! I emailed Janet Woodcock, the Acting Director of the FDA, last Friday - I didn...

  • Part of the tease was that Scott Gottlieb joined the board of directors. I found this on a google search- hope it helps...

  • I think this has to do with the biotech group, which has now has been finally realeased from all major restrictions, is ...

  • Hello Debbie, here is what I wrote back in November. The Taurx medication works for all kinds of dementia and is approve...

  • Why the FDA Just Fast-Tracked the "King of Genetic Sequencing" Jeff Brown. Does any contributors to this website have ...

  • HALO (part of PM's TM) got FDA approval for one of their drugs on Friday. But the price was already baked into the curre...

  • Yes, HALO got FDA approval. Not NNDM....

  • I think HALO is the one with FDA approval...

  • NNDM just got FDA approval...

  • Good advice, they got FDA approval today at 5pm. I got in after closing ....

  • I'm french, never heard about Jeff Brown before 20min ago (in an interview on Instagram)and it took me less than 10 min ...

  • I bought £10K Editas in 16th Nov and have this tripled my investment. That’s BEFORE final FDA approval of EDIT-101 fo...

  • I don't know but Jeff is pumping the teaser again saying the small cap is entering FDA Stage 1....

  • This link will bring everyone up-to-date with the latest covid-info; i.e. "cracking the FDA code for upcoming covid app...

  • Yes, EDITAS per my post several days ago. I’m showing just a slight profit since buying 2 weeks ago. Editas last Augus...

  • Charlotte's Web would surely have been a good candidate for 2019, don't remember if they were on the short list or not. ...

  • Yes, very happy I decided to hold my position on RYTM since September despite the stock falling to 20.87 only as recentl...

  • Yes, I'm also happy I held onto the stock and was indeed happy to see it go up 22% today upon the FDA approval, but I wi...

  • Travis, I bought some shares of this RYTM after I firs read this article back in Sept. 2020, on average I paid about $...

  • FDA grants first emergency use authorization for at-home rapid coronavirus test November 18, 2020 / 8:02 AM / AP U...

  • Lexagene is finally no longer just an R&D outfit, but an actual company with a real product. They announced this week th...

  • Safest mAB, proven in 1000 HIV patients already, subcutaneous injection (not hospital based infusion), can treat Cytokin...

  • Maybe not. Emergency Use Authorization — that’s how so many tests and treatments (and eventually vaccines) are gett...

  • One more thing. During this era of the CRISPER revolution, many new Biotech start-ups have come alive. Many of them are...

  • Thank you all for your thoughtful messages. Everyone's shared experience helps me to see the "real life of investing." ...

  • Thanks for your feedback. Yes, I feel the same way which is why I am not selling any of my position. At least will stick...

  • I bought RYTM in early Sept and now its way down 28%, so I am past my trailing stop. Normally I would sell all or part o...

  • Does anyone know why McBride says in his presentation that the computer vision company is waiting for fast track FDA ap...

  • Nick Hodge--not all gold resource companies. Lexagene on verge of commericialization. Vet sales first up. ttps://www.re...

  • "THAT"S WHAT I'M TALKING ABOUT" This is how we can win! One drug at a time at 'Warp Speed' 3 or 4 therapeutics then a ...

  • NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA ...

  • I'm with you both on staying away from biotech stocks. I'm an R&D scientist in the field and I've only bought my op...

  • The FDA gives the company staff and execs no room to say other than you heard Rhoady. The CEO is certainly not going to ...

  • That's what the company has been saying in presentations and filings all along, their focus is clearly on genetic disord...

  • All, the CEO was presenting at the Morgan Stanley healthcare conference a couple of weeks ago. I was streaming online an...

  • Attn: Shawna Welch https://clinicaltrials.gov lists clinical trials worldwide and is provided jointly by the US Nationa...

  • Most publications or stock groups have one or two extra special shareholders that go above and beyond and forward their...

  • Since using AC5 for say, bleeding from shaving that doesn’t stop due to your blood thinners isn’t yet an FDA approv...

  • Have not looked at it since I stopped out during the FDA conflicts last year. Will try to take another look soon....

  • If it weren’t for the FDA approval I’d give this one a miss because of the lock up period, the share price increase ...

  • I think I have found it also. Did an FDA "aspirin" search and Vitalis out of New York came up with Orphan drug status. ...

  • Good LORD! I am trying to sit through the insufferable presentation. Have been waiting for "The Three Words" from the FD...

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