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 […]

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

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

  • Travis Johnson, Stock Gumshoe

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

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    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...

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    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 ...

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

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

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

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

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

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

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

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    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...

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

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    $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...

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

  • SoGiAm

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

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

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

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

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

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

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    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...

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

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

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    NNDM just got FDA approval...

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

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

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

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

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

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

  • Travis Johnson, Stock Gumshoe

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

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

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    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...

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

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

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

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

  • Travis Johnson, Stock Gumshoe

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

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

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

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    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...

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    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...

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

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

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    "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 ...

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

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    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...

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

  • Travis Johnson, Stock Gumshoe

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

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

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

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

  • drbonz

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

  • Travis Johnson, Stock Gumshoe

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

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    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 ...

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

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    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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    Recent fast track status by FDA...

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    I was a member of Palm Beach Venture for the first year at $2k because I was a confidential member but did not renew. E...

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    He calls it the "Tiny biotech company". The company have one FDA orphan drug status for USA and one for Europe but here...

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    It’s important to know they’re probably large drug companies. The pre IPO drugs must have an FDA orphan drug status....

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    Abivertinib is under FDA trials (Sorrento Therapeutics - SRNE). Reportedly good early results. How does it contribute th...

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    I watched the "Set for life" summit last night and the two take aways form the number 1 pick are: 1. It's a biotech s...

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    Travis, can we check out frank curzio's tease for a small cap company with an oral covid 19 test which just got emergenc...

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    1. PSS lawsuit worth $1.2 Billion+ potential 2. BARDA funding, other government funding 3.CYNK-001 NK FDA Phase 1/Phas...

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    For all you following the 100x club, big news for one of the stocks, TTOO. FDA approves COVID-19 test. Stock is up 9% as...

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    Ascentage is developing anticancer drugs, and their first US trial (Phase Ib/II) was just approved. It can't be Ascentag...

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    If they are able to fast track this drug using the tools FDA has for rare diseases, and then use it, with FDA clearance,...

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    Honestly, I think this will take a very very very long time to gain traction once approved. No doubt this will be a high...

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    As a cannabis nurse educator, I am just going to say that all research studies that have been conducted, have proven tha...

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    I'd read these this article before buying this stock. https://kush.com/blog/natural-vs-synthetic-cbd-cannabinoids-everyt...

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    $ PAR:ASX Where we currently stand concerning funding and nice re-cap. Paradigm’s ‘ballsy’ move that landed it $3...

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    I've been a member of the Early Stage Trader since before the Covid crash and now look to trade the market daily. My 2 c...

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    Biotech companies Beam and Editas are set to merge. And they will release “exciting” details about their progress wi...

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    Just wanted to make mention of a Company called REVIVE THERAPEUTICS that was given FDA APPROVAL LAST FRIDAY ,3rd phase ...

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    Chris, I own stock in LXXGF. To my knowledge, their product, MiQLab, is not quite in production yet. It is a very ex...

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    Great to have you back. Hope you enjoyed vacation. Here’s some companies that I’ve researched that could be big co...

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    Interesting that you use the diagram of the three stages of this disease but do not mention Dr. Bruce Patterson who pr...

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    (RVVTF) Revive Therapeutics was approved by the FDA at Level 3 last Friday. Having spent countless hours doing my DD, I ...

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    I have been a member since around February. The entire membership is based on a fraudulent misrepresentation. In ...

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    I have listen to the presentation of Jeff Brown. The #1 timed stock should be currently trading between $14,5- $15, had...

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    I thought that the FDA doesn't approve of Hydroxychloroquine due to many health issues....

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    Why would you exit Novavax "soon" when 1) FDA approval is pending on Phase 3 of Nanoflu 2) Results from Phase 2 trials...

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    Major advancements in AntiAging are already being made via Nrf2 Activation. Many drug companies are trying to do it wit...

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    And one other thing I will add. The external trials really weren't that complicated or expensive. All things considered...

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    I have seen people talk about it the last few days......but I had no idea how to do it. Regardless - I was pretty much ...

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    Robinson"s pick is NIO. I did buy his Radical Profits just to get this correctly. I do not think this outfit is the ul...

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    There is a new pitch about CRISPER breakthrough with FDA approval??? Evidently will cure blindness.....

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    I believe he's talking about OPK (OPKO HEALTH INC). Here's a headline I found on briefing.com: Opko Health: FDA has auth...

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    I like the future for medicinal mushrooms and legal psiliscibin microdosing which has just gotten FDA approval The co...

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    Anyone follow Pluristem Therapeutics PSTI - they have a off the shelf ethical placenta cells which they inject into the...

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    Anyone follow Pluristem Therapeutics PSTI - they have a off the shelf ethical placenta cells which they inject into the...

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    Your right it is a lottery-i actually got indirectly lucky playing a micro bio-tech called trevena-trvn based on an fda...

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    I have not subscribed to the ipo service but have seen the presentation. Also in healthcare and familiar with FDA proces...

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    I have not subscribed to the ipo service but have seen the presentation. I’m also in healthcare and familiar with the ...

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    So we are a month out from the original marketing teaser. Have any of you subscribed, and have the "FDA approvals" move...

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    I'm a little skittish on any thing depending on FDA approval. I invested in Kite Pharmacies which was bought out by Gile...

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