alive and kicking
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Re: Split-face trial. About as favorable as you could ask for. If what he is reporting is typical of patients, has to result in sales. Too bad the market doesn’t seem to care or investors are focused on something else.
I share your cynicism regarding ENTA, but feel free to explain why you don’t like the stock.
Try to avoid somewhat snarky comments about another poster.
I just love it when the market lets me buy stocks I like at a discount. I have already increased my shares of ENTA by 25% since its drop after the successful EDP-235 phase 2 trial. I will be buying more.
I just love it when the market lets me buy stocks I like at a discount. I have already increased my shares of ENTA by 25% since its drop after the successful EDP-235 phase 2 trial. I will buy more
Novo Nordisk said it has filed lawsuits Tuesday against multiple medical spas , weight loss clinics and compounding pharmacies for allegedly selling unauthorized versions of the drugmaker's popular medicines Ozempic and Wegovy.
although I don't think a challenge study is particularly costly (and enables them to combine their drugs if any segment of the phase 2s has suboptimal efficacy)
Data from the Phase 1 study demonstrated favorable safety, tolerability, and PK supportive of once-daily dosing, with good exposure multiples, thereby supporting further clinical advancement of EDP-323. "With the significant unmet need for effective antivirals to treat patients with RSV, we are pleased to report positive Phase 1 results for EDP-323. These data demonstrate that EDP-323 was generally safe and well-tolerated up to 800 mg, with a PK profile supportive of once-daily dosing and strong exposure multiples across both RSV A and B strains" said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals.
What's your take on the demand for COVID boosters in 2H23?
Upcoming COVID boosters—>monovalent XBB 1.5, says FDA:
actually only up 3% I thought it might get a bigger bump
still nice though
I had one case during residency when we got bleeding from the vena cava when removing tumor (the surgeon was so calm I was shocked - stitched it up in 2 secs but we did abandon trying to resect that met)
anyway my point is that perahps by shrinking a tumor in a sensitive location around and in a vessel it can cause bleeding, but as far as I know this is not common at all
IMGN (MRSN)
I am sure you saw this news from a competitor company - IMGN should get a boost today from this
but you can also paint a picture where advil is just as good as paxlovid yet the latter is selling in the billions so it is clear that line of thought is delusional
Similarly, although ENTA had many performance sites when the summer RSV season hit (from my memory) Jay was talking about opportunities that may exist in the winter season and it did not seem like there was any progress for ENTA during the summer RSV occurrence.
"Engineered white blood cells can eliminate cancer, shows study"
https://medicalxpress.com/news/2023-06-white-blood-cells-cancer.html
In 2022/23 this class of patients weren't getting sick, they had the sniffles.
What You Need to Know
There is strong scientific evidence that antiviral treatment of outpatients at risk for severe COVID-19 reduces their risk of hospitalization and death.
The antiviral drugs nirmatrelvir with ritonavir (Paxlovid) and remdesivir (Veklury) are the preferred treatments for eligible adult and pediatric patients who are at high risk for progression to severe COVID-19.
Clinicians should consider COVID-19 treatment in patients with mild-to-moderate COVID-19 who have one or more risk factors for severe COVID-19. Treatment must be started as soon as possible and within 5 days of symptom onset to be effective.
Risk Factors for Severe COVID-19
Clinicians can use the links below to identify patients at risk for severe COVID-19 and who may benefit from outpatient treatment. Severe outcomes of COVID-19 are defined as hospitalization, intensive care, ventilatory support, or death. There may be other medical conditions associated with severe COVID-19 not listed here, and clinical judgment is needed.
Age is the most important risk factor for severe outcomes of COVID-19.
Risk factors for severe COVID-19 include:
Age over 50 years, with risk increasing substantially at age ≥ 65 years
Being unvaccinated or not being up to date on COVID-19 vaccinations
Specific medical conditions and behaviors
Some people from racial and ethnic minority groups are at risk of being disproportionately affected by COVID-19 from many factors, including limited access to vaccines and healthcare.(1-3) Healthcare providers can consider these factors when evaluating the risk for severe COVID-19 and use of outpatient therapeutics.
Now that Plax has full approval, they should run a head to head ph2 trial and even if they are just equivalent to plax their the winner.
Their patient selection was a group of young people that any reasonable doctor would prescribe to take 2 Tylenol for a couple of days.
The amount of time for the RSV trials has been difficult to reconcile, and I am not totally convinced of the list of performance sites as far as I wondered if some were the best suited and I wondered why others were not utilized.
I like to play both sides to get reactions. This is a message board, no?
RVNC has been a long term holding but my financial future is hardly riding on it. I made my money with covered calls and mostly during the waiting, but my position is now much smaller than it has ever been. In that sense I guess I should be grateful for their incompetence. Overall, my vacillation probably comes down to my inner conflict between what I see as a profitable drug and the sub-par management outfit trying to sell it.
It is amazing to watch IMGN stock price go up day after day. I am a long time IMGN shareholder so you can be sure that pleases me, but it is still amazing to see.
The FDA should determine the cause of worldwide post-COVID excess mortality before recommending further shots in any format IMO.
For now I think ENTA's value is not in hep but in covid and rsv (and the patent suit which is a wild card in all of this)
Muddy Waters is short KDNY—thinks Atrasentan not approvable:
The core inhibitor is interesting in that it shows this mechanism could lead to lower hep surface antigen
Precarious time? You've got to be joking. Sounds like you cannot handle the volatility and should sell and move on.
Those aren't random nobodies - they aren't Dew but they follow biotech closely have thousands of followers. This is a precarious time for the company or a temporary lull. I nor anybody else knows how it plays out, but I'm concerned where things are currently sitting and I'm sure others are as well. If you don't like it, tough shit
First, yes I am aware that heterogeneity exists and the impact of clonal evolution under selective pressure.
The key word here is "relatively." And yes, while there are few broad tumor types that have a single driver (like CML), there are many molecularly defined subsets of tumors that are driven predominantly (but perhaps not completely) by a single targetable mutation (ALK, ROS1, EGFR, etc in NSCLC).
But you are making my argument from an investment standpoint for me. Okay so a particular combination will work for the 0.5% x 0.5% of patients who carry both actionable mutations. Do I want to be involved from an investment standpoint in the development of such combinations? No. Great for patients, not great for investments.
I am not arguing at all about the value of precision medicine for patients, I am only making the point that as the molecular pathophysiology of cancers is further dissected, treatments will become increasingly targeted to smaller populations. Either a) the populations become so small that the company will never make money or b) therapies will become so extravagantly expensive that nobody will be able to get them anyway.
This is in contrast to inherently highly polygenic diseases like RA, ulcerative colitis, or multiple sclerosis, where they are so highly variable that precision medicine just doesn't really work yet (and will not for the next several decades). Thus they are still a viable investment because the drugs that come out can treat broad populations. Companies researching diseases of consumption like NASH and obesity also remain highly investable due to the size of these populations and the fact that precision medicine is largely irrelevant in this space, with the exception of the small population of patients with strong genetic drivers of liver disease or obesity.
Biotech investors (including analysts, CEOs, and myself in the past) confuse clinical utility with investability. My argument is that there is very little barrier to entry into the ADC space--identifying differentially expressed targets and attaching a cytotoxic molecule to them is relatively trivial. My argument is are they are not investable *moving forward*.
ENTA’s 8-K re leasing space in new building:
Actually, when the Jefferies analyst proffered a range of $100-200M, Jay Luly responded without hesitation by saying, “North of that,” which strongly suggests that Luly has a specific number in mind. That Luly has a specific number in mind further suggests that ENTA and/or a prospective partner have given serious consideration to the design of the phase-3 trials.
I listened the talk Jeffries today. It was very uplifting to me. Jay Luly stated that there is sufficient EDP-235 for phase 3 trials, which is reassuring. He also explained a big difference in the Shionogi trial and the EDP-235 trial. For the Shionogi trial the number of nucleocapsid positive patients (i.e. previously Covid infected) was in the single digits whereas it was some 70%-80% in the EDP-235 trial. That would explain why an overall virus decline was seen in the overall population in the Shionogi trial and was also seen in the new analysis from ENTA in nucleocapsid negative population in the EDP-235. Looking at only nucleocapsid negative population in the EDP-235 trial is an apples to apples comparison, and should remove any doubt that EDP-235 has potent anti-viral activity. Well, the statistically significant improvement in symptoms for EDP-235, which Paxlovid failed to show in a standard risk population, should have already made that crystal clear. Still it is nice confirmatory bit of data to see even though the FDA wouldn't base any approval on viral reduction in nasal swabs.
The Jeffries interview was fair but tough and pointed. He made it clear that EDP-235 showed symptom relief and Luly reiterated that Paxlovid failed to do so even with a mostly nucleocapsid low population. They talked about IC90 and Luly pointed out the bar has been raised for new drugs as EDP-235 has reaches a much higher drug level with regards to IC90 than Paxlovid, and that likely explains symptom relief. Yes the Jeffries interviewer/host pressed about timelines not only for EDP-235 but for RSV drugs. There was some ballpark figures about the cost of 2 large phase 3 trials for Covid and it was $100-$200 million. Luly did point out the China was experiencing a major surge in Covid cases. Luly refused to get drawn in and make specific comments. Obviously there are no guarantees, but overall I came away more confident about ENTA and about EDP-235 and ENTA.
I recognize the accomplishment(s) that Enanta has had, and I think Enanta has at times overstated its wins and understated its losses. I was very much bothered many years ago when at least in my mind Enanta dropped a program without providing much information at all. Today it feels like Enanta may be utilizing a "let it linger" approach with regard to EDP 305 and 297.
Also there is information on the internet about a new building for Enanta operations, this has been intermittently discussed on this board, but I think this is actually a big deal as far as interrupting operations and probably financially as well. The talk with Jeffries this week was not uplifting. However, I did think I heard Jay say he has drug for the phase 3, please correct me if I am wrong, if that is true that there is right now sufficient drug to conduct the phase 3, then this is a big deal.
I disagree
but to be clear enta didn't state if the data is stat sig or not (i presume if you combine the 2 drug arms to placebo to up the N that it is stat sig but again I don' think it matters)
ENTA Pfizer Case One can sort of follow the case from a site called PacerMonitor. Also, there is a May 5th, 2023 document from the case available to view by searching in Google Case 1:22-cv-10967-DJC
ENTA reports additional post-hoc EDP-235 analyses_from_ phase-2_trial—details_in_new_corporate_slide_set:
ENTA reports additional post-hoc EDP-235 analyses_from_ phase-2_trial—details_in_new_corporate_slide_set:
I point out several of your contradictions in your own writings, where you actually lay out your thoughts but you don't or cant explain the error, contradiction or weakness in your argument.
Instead, you change the subject with pure whataboutism.
And in that you seem to feel that the next gen Pfizer drug has great potential I infer you must also agree. What I cannot grasp is how in your mindset that approval is possible for competitors, but also somehow impossible for Enanta's EDP 235.
Nice interview of the IMGN CEO at ASCO after the presentation of the MIRASOL data in PROC. He also talks about why ADCs appear to be making a nice comeback as anti-cancer therapies. Worth watching and encouraging for IMGN investors.
https://www.biotechtv.com/post/mark-enyedy-june-4-2023
Nice interview of the IMGN CEO at ASCO after the presentation of the MIRASOL data in PROC. He also talks about why ADCs appear to be making a nice comeback as anti-cancer therapies. Worth watching.
https://www.biotechtv.com/post/mark-enyedy-june-4-2023