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Right. It isn't looking good. Hasn't looked good for a long time.
It's still right to wait for something good to happen before going long, if one is still looking at going long.
There are funds getting it off the books before the end of the Q and some other capitulation going on, but yeesh.
https://investors.ocutx.com/events/event-details/ocular-therapeutix-2024-investor-day
It has been linked in other posts, including a prior 'sticky'.
One conflict I have seen in the slides regarding "at risk".
https://investors.ocutx.com/static-files/9a2366eb-bf3f-45d8-b6f4-8aad4928c536
#57 says final design pending FDA Type C feedback, while #47 footnote 1. states the trial is being initiated prior to the type C meeting.
Although it may not actually be a conflict as the trial could be initiated but not started, as happened with Sol-1 last year and then the trial was modified with a new SPA. So both may be accurate!
My recollection from other parts of the presentation was in alignment with slide #57.
Lastly, regulatory risk is primarily due to no SPA and no one having yet had a drug approved under the new guidelines. I don't consider the risk to be much different than many other FDA approvals, again waiting to see if there are significant design changes or warning more strongly worded.
Presumably Sol-R.
Feel free to delete this post.
OCUL
GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company's Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1
Since we're looking at these things today. A 3m cap co, with a (S) and (N) approach that they think will require infrequent modifications or updates.
https://finance.yahoo.com/news/geovax-receives-barda-project-nextgen-110000120.html
I was today years old when I first learned about this co.
From the guidelines:
OCUL
One question that did not come up and is something that makes me wonder is about the re-dose schedule for Sol-R.
Comparing EYPT and OCUL trials as proposed:
EYPT @ 6 months - drug gone, some % of patients need rescue prior to re-dose, carrier vehicle still present to some degree.
OCUL @ 6 months - drug and carrier present, prior rescue unlikely, carrier vehicle still present to some degree.
I haven't found it in slide decks (thus far) but going from memory OCUL is designed to release a final amount of drug at the end of life of the carrier around 8-9 months. By comparison EYPT drug is clearly gone by 6 months and I don't recall the expected eluting pattern, however they had >10% 'supplement' (rescue) at 5 months and > 20% at 6 months. https://investors.eyepointpharma.com/static-files/2f2e6f27-26f6-400f-9e52-a3fec5885ea7 with roughly 2/3 rescue free at month 8.
Both have some kind of "stacking" issue with the carrier at 6 months that probably isn't relevant for the majority of patients.
I do wonder what the effect of having extra drug in the eye for 2-3 months is versus not having enough drug to sustain stable vision for what is probably a high percentage of patients on the other hand. (Current SOC patients also have the problem of the drug being gone, by definition. That is one compelling point of sustained release.) Also, EyleaHD should make my concerns irrelevant?
In practice with approved drugs the dosing schedule would be adjusted to the patient need as insurance allows, which is mostly guided by label.
Given the OCUL team has a lot more experience and success designing registrational trials for AMD than I have criticizing such trials, I wouldn't make too much of this commentary and, if successful, the OCUL re-dose trial should be fantastic commercially.
The most recent event EYPT stated that sham is "allowed" and that they are still waiting on the written notes from the meeting. That was earlier this month, as mouton29 alluded to.
The Vabysmo trial LUCERNE used a sham w/ no needle, no injection.
And, I think asking for that kind of trial design using an eluting vehicle is asking to create a complication rather than a solution.
Just a comment on your point 2) regarding SOL-R without addressing the rest of the post.
1. The trial design is not finalized IIRC they still need a type C meeting.
2. This IS a re-dose trial, which is kind of a big deal and the primary reason for the trial IMO. You could consider non-inferiority as a co-primary reason. Note that the Axpaxli and comparator arms get redosed after 6 months.
SMMT
Word is it was Baker Bros, and if so it doesn't amount to that big of a bet for them (they already had a position, not sure how big) and still useful for SMMT.
https://www.smmttx.com/pressrelease/summit-raises-200-million-also-expands-license-territories-for-ivonescimab/
It looked like a clarification of US practice, and a note on SOC that might affect the trial/ China difference.
Regarding Atezo+avastin+chemo 1L his comments:
Yes it’s a 1L option per nccn, and some providers use it selectively in younger fit patients. Anecdotally I don’t see it used much
— Epoch (@EpochSwing) May 31, 2024
A comment seen on X:
$SMMT just fyi, in the US we save the VEGF for 2L Docetaxol/Ramucirumab. I’m guessing any OS benefit in china, if seen, would be due to SoC difference btwn US and china (availability of Cyramza). We tend to avoid the existing VEGF/PD1/chemo option in 1L intentionally
— Epoch (@EpochSwing) May 30, 2024
BHVN
the deck for anyone interested - 217 slides
https://ir.biohaven.com/static-files/902e8b1a-ebde-4e7f-8414-13063467bcf0
FWIW - underperformance after being featured on "South Park"
Once a company or its product is featured prominently on an episode of "South Park", its stock tends to underperform over the next 12 months. https://t.co/rv2aNEcHj1
— Sherwood News (@sherwood_news) May 29, 2024
I'm not following that closely. Among those that do, it was felt that the program was likely to disappoint. There is an article from STAT for those that subscribe.
Updated with comments from CEO Vlad Coric: $BHVN Biohaven protein-degrader drug falls short of investor expectations in early-study test https://t.co/D6rPMy3lS3
— Adam Feuerstein ✡️ (@adamfeuerstein) May 29, 2024
The degrader.
looks like this one:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174503954
Yeah, it's really hard to comment on the results without further breakdowns, some of which you provided.
The biggest problem was the size and duration of the trial. The data as presented showed the 400 mg arm as indistinguishable from placebo. That shouldn't be a surprise just given the trial design - any or all of the arms could have looked that way. Nothing about the trial suggested they would be able to achieve and maintain enough CST improvement to be clinically meaningful and, oh by the way, the FDA does not use CST as an endpoint.
That they showed a P value for separation of placebo and 200 mg was extremely disingenuous. There was no valid statistical examination for that data set. And a drop of 30 µm from a baseline of something over 300 µm in twelve weeks means nothing. You are in OCUL if I recall. The P1 they ran in Australia had a small cohort of treatment naive AMD patients drop from 484 baseline to 232 over the same time frame picking up 17 letters BCVA in the process.
So I would guess that if there is a drug there it is slow acting and/or weak. I would guess it would take a 12 month trial to have a chance to show something.
RVNC
Kind of down the middle. Step in the right direction.