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Kaiser is a very busy guy, but he is very interested in DR and thinks $OCUL has the potential to make it practically treatable.
ij
The simple answer is that Dr. Kaiser was working for OCUL less than 50% of the time. Rather than be in violation of an employment covenant, he renegotiated the contract.
I wonder what the full explanation of “to eliminate his 50% service requirement” entails? As it doesn’t imply otherwise, I assume he still holds the position without the service “requirement”.
OCUL—I am impressed with their executive hires announced this morning. along w/ Dr. Kaiser, this is really a great team.
On March 28, 2024, Ocular Therapeutix, Inc. modified its employment agreement with Peter Kaiser, M.D., its Medical Director, to eliminate his 50% service requirement under the employment agreement.
[XLO] is a penny stock, isn't it?
How do you know if Chat GPT didn't summarize the key pts accurately ...unless you actually looked up the FDA doc. ?
You can't .
AI - FWIW
I have been using several AI engines. Sometimes I ask the same question of each.
Claude3 and Gemini are the worst for my queries. Claude frequently comments it is not current and thus cannot inform beyond August '23. Gemini likes to make you refine your query and then tells you all the reasons it cannot answer.
Perplexity and Pi are my favorites in that order, but it is close. ChatGPT (CoPilot uses it) is good but so far not as good as Perplexity and Pi.
I have read that MSFT CoPilot will be processing some of the requests locally and taking some of the processing off the cloud to speed things up. They are going to require computers to not only have the normal CPU's and GPU's but also a NPU capable of operating at over 40 TOS.
The time saving in getting basic information together is enormous. As others have pointed out, we cannot trust the answers blindly. I have noted some. But these tools are just getting started. For those of us who are not geniuses or topic experts, the tools are good today and in a couple of years we won't be able to spot errors if there are any.
How do you know if Chat GPT didn't summarize the key pts accurately ...unless you actually looked up the FDA doc. ?
You can't .
The value of this board , to me at least , is that generally posters will back up their pts of view with links supporting their opinion.
Kiwi
Re: XLO
This is a penny stock, isn't it.?
Bladerunner
Right.
There are ways to use AI to speed the search but you still need to check the results, they even spew out false references sometimes.
Of course, there are ways to search the text of a specific webpage or .pdf and some of those are via AI. That makes it faster to find specific text or to locate keywords. Old technology that predates AI can be pretty efficient.
I've overspent my daily 5 minutes on this site today. Later.
Exactly
Except it’s time consuming. If you can get references for the answers from searches that would be an improvement bc then you can judge the trustworthiness of the sources
We all know there is misinformation out there and my understanding is that current generation of AI can’t always distinguish good from bad sources. Chatgpt could be correct here but If it’s garbage in then it’s garbage out
So how about getting the correct answer ...copy and pasting it for us so we can see how accurate ChatGPT was ...and the time it took you to find the answer.
I'm not saying ChatGPT is perfect ...its obviously a work in process ..
So how about getting the correct answer ...copy and pasting it for us so we can see how accurate ChatGPT was ...and the time it took you to find the answer.
I'm not saying ChatGPT is perfect ...its obviously a work in process ...and I'm biased as NVDA has been my 1/3rd largest position for the past 10 mths
Kiwi
Where is that mentioned in your links ( copy and paste section ...thx ) and how much time did you spend finding it ?
Well the question was ...Market exclusivity following approval .
Where is that mentioned in your links ( copy and paste section ...thx ) and how much time did you spend finding it ?
Kiwi
Why even ask ChatGPT when you can go to source material?
FDA Breakthrough Devices Program
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
Guidance PDF
https://www.fda.gov/media/162413/download
PHARMACEUTICAL TECHNOLOGY research news via GlobalData -
March 29, 2024
Enanta Pharmaceuticals gets grant for inhibiting coronavirus replication with compound of formula (i)
Enanta Pharmaceuticals has been granted a patent for compounds that inhibit coronavirus replication. The patent covers pharmaceutical compositions and methods for treating or preventing coronavirus infections. Claim 1 specifically pertains to a compound represented by Formula (I).
Excerpts:
Additionally, the patent includes claims for pharmaceutical compositions comprising the disclosed compound and methods for treating or preventing virus infections, specifically coronavirus infections such as those caused by 229E, NL63, OC43, HKU1, SARS-CoV, or MERS coronavirus.
The patent's claims highlight the compound's versatility in treating various virus infections and respiratory disorders, positioning it as a valuable asset in the field of antiviral and respiratory therapeutics.
Read more:
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-gets-grant-for-inhibiting-coronavirus-replication-with-compound-of-formula-i/
ChatGPT's answer
Some more :---)
Exclusivity Period: The FDA may grant market exclusivity to a Breakthrough device for a period of time after approval. This exclusivity typically lasts for a duration of one year from the date of FDA approval. During this time, other manufacturers are generally prohibited from marketing a substantially similar device for the same indications.
Competitive Advantage: Market exclusivity provides the manufacturer with a competitive advantage by allowing them to establish a presence in the market without immediate competition from similar devices. This can be especially beneficial for smaller companies or startups looking to gain traction and market share.
Post-Exclusivity Competition: After the exclusivity period expires, other manufacturers can seek FDA approval for similar devices. However, they may still need to demonstrate substantial equivalence or meet other regulatory requirements, which can take time and resources.
Thanks—good to know!
ChatGPT's answer
Market exclusivity following FDA approval of a Breakthrough device refers to the period during which the FDA grants certain benefits to the device manufacturer to encourage innovation and expedite the availability of breakthrough medical technologies to patients. This exclusivity period provides the manufacturer with a competitive advantage by temporarily limiting competition from similar devices.
An FDA breakthrough designation does not entitle the manufacturer to a period of marketing exclusivity, as far as I know. Maybe you are thinking of an FDA Orphan Drug designation, which confers 7 years of marketing exclusivity.
Yes ...Breakthrough designation if approved grants market exclusivity for ??? years ?
Kiwi
Thanks. The word, "circuit" refers to the dialysis loop, right?
TEVA sues AMRN for_alleged cornering of Vascepa API:
https://www.fiercepharma.com/pharma/teva-follows-suit-after-hikmas-2023-complaint-arguing-amarin-locked-drug-ingredient-supply
According to Teva, Amarin inked multiple exclusive agreements with API suppliers in which the company agreed to purchase minimum ingredient amounts in exchange for exclusive access to the supplies.
Dew. a more specific answer to your questions re TLPH
Niyad granted FDA breakthrough device designation status for use as a regional anticoagulant in patients receiving RRT who cannot tolerate heparin or are at a higher risk of bleeding.
Nafamostat expected to act as a regional anticoagulant in the circuit, enabling FDA regulation of Niyad as a device
Nafamostat has an 8-minute half-life, resulting in rapid clearance from the blood
Niyad would be the first FDA-approved regional anticoagulant for the extracorporeal circuit
TLPH. as follow up
https://pubmed.ncbi.nlm.nih.gov/38292627/
Conclusion: Treatment of patients showing end-stage renal failure with Nafamostat mesylate can significantly improve therapeutic efficacy and has high safety and clinical value.
Housekeeping reminder—A link to the latest version of Mufaso's compilation on oral weight-loss drugs resides in the shaded box at the bottom of the main screen for the Biotech Values message board. (The link is immediately below the one for Biotech Buyouts/Premiums.)
TLPH. Hi Dew ...understand that this is a layman's read . My wife who rounds dialysis clinics is loath to discuss her work / patients unless she initiates the conversation / vent.
The issue is primarily in the ICU dialysis setting . Heparin and Citrate have relatively long half lives and recirculate from the dialysis lines back into the patient . These patients in the ICU often have bleeding issues and may be intolerant to Heparin and Citrate.
Nafamostat has a very short half life so far less of it gets recirculated back into the patient. .
In non ICU dialysis its use may be for those intolerant to heparin and citrate .
My quick layman take
Believe its FDA designated as Breakthough and they agreed to device track for approval based on extensive history in Korea and Japan
Kiwi
Questions about TLPH:
Is nafamostat intended only for ICU dialysis, or for dialysis in general?
How is nafamostat superior to other anticoagulants used in dialysis?
Why is the FDA treating TLPH's nafamostat as a device rather than a drug?
TIA
TLPH. Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi
Aardvark Therapeutics—(private)—has_dual-acting_small-molecule weight-loss drug_in_phase-2:
https://www.ft.com/content/e3c4130d-494d-4f69-b5fe-81833f88caed
Aardvark Therapeutics, a US biotech group developing a weight loss pill, is planning to raise up to $200mn in an initial public offering as early as this summer… Aardvark’s lead drug—ARD-101—has succeeded in suppressing hunger cravings in patients with Prader-Willi syndrome, a rare genetic form of obesity, in early-stage trials. It has shown the same promise among people with general obesity.
…Investors are excited by ARD-101, a so-called TAS2R agonist, because it does not just activate GLP-1, …but it also harnesses CCK. This second hormone could limit widely reported side effects of nausea and wastage of lean muscle mass associated with GLP-1 drugs.
Its a Mark Twain quote and you can google it:
"Figures don't lie, but liars figure." Through this early quote, Mark Twain ruminates about deceptions run rampant; numbers used by phony wizards as illusions of truth, while feeding people's hunger for answers prescribing the calming paregoric of snaky prevarications
Liars game? Could you expand on this? Thank you! Randy
The clinical study of 391 subjects found that patients taking Altimmune’s Pemvidutide loss an average of 16% of weight after 48 weeks. Of that weight, 75% of it derived from a loss of fat, while only 25% came from a loss of lean mass. This ratio is comparable to weight loss achieved with diet and exercise.
For comparison, a clinical trial of the active ingredient in Wegovy and Ozempic looked at a subgroup of 140 patients to see its effects on lean muscle mass. Participants in this group lost an average of about 15 pounds of lean muscle (40%) and 23 pounds of fat (60%) over 28 weeks.
Re $BTTX: By restructured I mean a new loan for the company.......has nothing to do with shareholders.......
Z
I guess I have spellcheck spellcheck more often.
VKTX—So how does that [infographic on the advantages/disadvantages of peptide drugs] translate to VK2735 in your opinion?
XLO—I'm still bidding 1.20's in afterhours as I'm 100% certain GILD knows more than I do concerning this specific matter.
BTTX—Debt can be restructured…
And everybody involved believes in the AspireRX product…
XLO 1.25 - (clarification) 8K released afterhours:
Item 8.01. Other Events.
As previously disclosed, in connection with Xilio Development, Inc., a wholly-owned subsidiary of Xilio Therapeutics, Inc. (the “Company”), entering into an exclusive license agreement with Gilead Sciences, Inc. (“Gilead”), on March 27, 2024, the Company entered into a stock purchase agreement with Gilead pursuant to which the Company agreed to, among other things, initially issue and sell 6,860,223 shares (the “Gilead Shares”) of its common stock, $0.0001 par value per share (the “Common Stock”), to Gilead in a private placement at a purchase price of $1.97 per share, for an aggregate purchase price of approximately $13.5 million (the “Initial Gilead Private Placement”). The Initial Gilead Private Placement closed on March 28, 2024.
As of March 25, 2024, the Company had 27,613,263 shares of Common Stock outstanding. Following the issuance of the Gilead Shares upon the closing of the Initial Gilead Private Placement on March 28, 2024, the Company had 34,473,486 shares of Common Stock outstanding.
https://www.sec.gov/edgar/browse/?CIK=1840233&owner=exclude
I'm still bidding 1.20's in afterhours as I'm 100% certain GILD knows more than I do concerning this specific matter.
Debt can be restructured.........And everybody involved believes in the AspireRX product.........fwiw
Z
Jbog- I agree the pricing should and will drop. How much will depend on how many people actually take the drug. What is the key here and I hate to sound like a broken record but the answer is tolerability.
Goldman Sachs projects that between 10 million and 70 million Americans will be taking weight loss drugs by 2028. You might think Goldman is of base with such a wide variation but they are not in my opinion as it depends on tolerability and price. (Note- nearly 40% of the US population is obese so 70M is less than half and that's not counting people who are just overweight)
The total market could remain $100B (or you pick the number) and once you know how many people are on the drug, you then know the approximate pricing. (At one time Lipitor was the biggest selling drug of all time and it didn’t have that high of a retail price.
Lots of variability here but I think enough competition and manufacturing capacity will eventually exist so that the manufacturers and the insurers come together and come to a figure like you suggest. (I think your $200 to $300 is likely once an exceptionally tolerable drug like VK2735 is on the market for a few years
PS- In your post I think you meant ludicrous not lubricous. Check out the definition of lubricous at Dictionary.com https://www.dictionary.com/browse/lubricious or better yet just google it. LOL
BTTX…has dropped 92% from $1+ price only 8 months ago…
Thanks I’ll check out the study. The typical confounders in observational cohort trials like this are really controlled for here so it sounds like this could be pretty compelling data
RE the study published June 2023 about Wales data set - from https://finance.yahoo.com/news/vaccine-may-help-protect-against-161500715.html
>>>>>>>>>>>>
The study took advantage of something that happened in Britain in 2013, when the country’s National Health Service rolled out shingles vaccines for everyone born on or after Sept. 1, 1933, but completely excluded those born before that date. Pascal Geldsetzer, a professor of medicine at Stanford and one of the study’s authors, says this created a real-world experiment similar to the kind you get in a lab, where people of similar age—in some cases just a few days or weeks apart—were randomly assigned into two groups.
“We are able to get credibly a causal effect because we are able to exploit this really unique way that the shingles vaccine was rolled out in Britain in the National Health Service,” he tells MarketWatch. “It allows us to compare people who differ by just a week or two in their age. I think it’s a really neat, clean way to mimic what we would do in a clinical trial.”
Incidentally, these U.K. numbers might significantly understate any impact of shingles vaccines on future dementia, although we cannot know for sure. In most cases, those who got a vaccine only got one, rather than successive boosters. The follow-ups were only within seven years. And the study looked only at those who were given the vaccine in their 70s or older.
>>>>>>>>>>>
$BTTX - Super Bounce? - Easter Special
Has dropped 92% from $1+ price only 8 months ago
Mufaso,
With the lubricous pricing that Novo started with I also thought there will be the $1000 drug, maybe a $700 and maybe a $200 Drug. I've always claimed that the measuring stick of how much you can lose in xx weeks is absurd. Just put the people on a trendline as comfortably as possible.
ENTA is quietly +70% since the post I’m replying to from six months ago.
Moral: A dirt-cheap valuation can be a strong catalyst in its own right.
Please elaborate. TIA
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