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would have been nice to have them meet a year ago - I don't think the data hasn't changed or patients been enrolled over the past year.
about the only good thing I see here is that with the data being unblinded (and I agree that they had looked at the 210 and 500ish) maybe a 'partner' that they may be talking to can now discuss with the FDA an agreement on a fresh study / endpoints and hopefully that partner has the expertise to run a fairly quick trial under new endpoints, Basically they waited too long the trial fizzled with no push towards enrollment.
I agree with you - no sense pulling the trigger here - I'll just hold tight and see what the next 3 - 5 years bring.
don't get too anxious - if they decide to continue the study, they'll probably need to still get an infusion from a partnership; change end points and start over. If they decide to stop the study they'll need an infusion from a partnership and restart a study with different / changed endpoints. Even if they say it's the greatest thing since sliced bread the endpoints are antiquated so they'll need an infusion from a partnership and restart a new study with different endpoints. I don't think with the current endpoints that the FDA will be impressed. The study just took too darn long with those endpoints.
no matter the decision, it's going to take time and $$$ - probably just a matter of getting the data to where they can get a potential partner to look at what they've got and decide whether they (potential partner) want to fund further trials.
Did you notice that they're down to two outcomes? continue the study OR halt due to significance not likely to be met. No longer looking at halting due to efficacy.
it's easy to play with percentages - but keep in mind thata 17.5% increase comes after a 66.7% decrease (just speaking roughly of the .15 to .5 drop I could site worse.
agreed I was referring to the letter. A shareholders mtg (scheduled and publicized) wouldn't be a bad idea.
no one here is an expert - just folks posting their views / opinions.
I'm thinking even IF the data shows BUC works for hospitalizations, Revive will still have difficulty getting approval based on that since it's not as pertinent as it was at the time the data was taken IF it is effective, the data should have been unblinded a year or so ago and submitted at that time. MF is now stuck between a rock and a hard place.
Probably the only way he could respond. If he sends any type of material info in a letter to just some folks and it is acted on, it's sort of insider trading. He probably tried to hit on the questions while at the same time saying he's not going to respond to individual letters / emails with anything he feels is material. True that it gave the impression of thumbing his nose at the letter, but the response had to be expected by BMT if he knows about how this stuff works.
Thanks - i'm all for a review of leadership - just the first I heard about it. Change of leadership or not and while I know the study is already in motion, the focus needs to not be so much about Covid but an overall conversation (MF did imply that he was going to take this route) with the FDA about usage of Buc in general based on it's history.
so do we know who this committee is that is interviewing / doing a search for a new CEO?
but at least it's 50% more likely to keep you out off the hospital (3 for pax vs 7 with placebo).
I do my own DD - anyone that relies on info posted on a board isn't being real smart. I do pay attention to what folks are saying here, but don't use it as gospel for my decisions.
Even the reddit post I provided to you is only a post. Do with it what you want. Folks that have truly been around for a couple years already know where I stand - no need to either trash talk or thump my chest here.
This isn't official data / link you're looking for, but it as analysis frorm BMT - I could try to go back farther, but I'm not in the habit of spoon feeding folks - maybe spend a bit of time andd you'll find the data you're looking for, take a look at the last line of the paragraph before 'final thoughts' where it says 'since we had 140 patients taking bucillamine and none of them were hospitalized or died of COVID'.
https://www.reddit.com/r/RVVTF/comments/ritbjd/where_we_stand_on_the_trial/
If I were RVVTF I would work on it day and night (and weekends) and get it submitted asap - we'll have to see how quickly they actually move.
They didn't say they wanted the data again - they want the primary EPs detailed more to reflect the data.
Sounds like they want the primary endpoints to include whether a person relapsed and the 'long term' effects. Basically the FDA seems to be saying - include additional descriptions for the endpoints and adjust the SAP to match.
Next question is how long will it take RVVTF to do adjust and re-submit and then how long for the FDA to review / rule on it.
This is where having someone in constant contact (at a desk in the building?) with the FDA (this is where the bigger companies have the advantage to interact) would help expedite things.
The question before the FDA right now is the changing of the primary endpoint. It's not one of approving or denying the EUA - while the FDA can technically decide anything it's not likely that they will decide anything other than the trial has to stick with the existing primary ep or can change the primary ep - OR I guess they can come back with a maybe - but that would then be accompanied by a further request for clarification. At this point i doubt the latter will occur. just a yes or no on the primary ep change. Anything beyond that would surprise me.
not necessarily tomorrow -- that's only a target date.
Revive submitted additional info about a month after that date was set - it may or may not affect that date. PR has been deafeningly silent since that supplement.
For what it's worth, here are my thoughts:
I doubt this decision would be for more trials since there is additional data that isn't submitted yet - what's before the FDA right now is changing the end points based on the first 240 patients in the trial. I would think the outcomes would be either 1) yes, we approve the change in the primary endpoints; 2) We're not convinced and want you to unblind the remaining data; or 3) no, you cannot change the primary endpoints.
I would hope the data on the first 240 at least lends itself to one of the first two and not the latter.
once that decision is made, then Revive would have to decide how to proceed next (ask the DSMB to make a recommendation on whether to unblind the remaining data (if not requested by the FDA); continue the trial; or shelve it.
keep in mind that March 7th is a 'target' date not a deadline.
What I haven't heard is whether that target date moved when they provided the supplimental information after the initial submission.
you noticed that too! :)
I'm a bit confused by the PR (what else is new) - it says they granted the type-c meeting but then goes on to say the FDA has a goal to provide it's 'written' response by March 7. I'm assuming that means the mtg would not be before March 7 (if still needed)?
my understanding of the type-c meeting is that the sponsor had questions. The submission was supposed to have a response to the question(s) along with the request for the mtg. If the answers were sufficient there may not even be a mtg - but in any event the 75 day clock starts today.
Thank you - lots of good info to digest.
Ecomike - I'm interested in your thoughts on something in today's PR.
As one of the secondary endpoints they stated: "... and disease course in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo."
I'm wondering if they maybe did any type of follow-up after unblinding the data (for the first 210) to capture possible long-term Covid data that wasn't part of the study early on.
Also curious as to if/when BUC gets an EUA and FDA Approval, would they be able to get approval to treat long-term Covid (where folks were not part of the study but now have LTC) based on this study or would they need to run a separate trial (maybe brief, but still another trial) to evaluate folks taking BUC now that they have LTC?
One step closer - now it's back in the FDAs court.
Seems each step is about 4 weeks (sorry - that's the math guy in me).
Thank you. I really do hope you're right.
Forgive my simplicity Rick, but I really don't follow your post. No matter how good the research is (and I'm not questioning that at all), speculation on share price once approved; in my opinion; is just a bit premature. Guess I'm just real conservative in that approach. Probably just that the line of work I'm in that doesn't allow for these types of timelines.
most of that seems like common sense to me. Pretty much a playbook for any type of presentation / proposal I work on also. Hopefully they already have some of that 'homework' done?
I hate to break up all this dreaming, but it's been 4 weeks since the unblinding - still waiting for the 'shortly thereafter' submission of the end point change. At the rate they (RVV) are moving this thing may go the route of the Gout clinical trial.
I wonder if it wouldn't have been quicker to raise the money needed and just complete the trial.
So far we know that 'shortly thereafter' is at least 21 days. Hopefully 'shortly thereafter' is followed eventually by 'happily ever after'.
We continue to wait.
Not frustration - Turkey never started enrolling patients. There is data from the US (approx 715-750) but no data frorm Turkey.
It will be included 'shortly thereafter'.
It will be included 'shortly thereafter'. :)
I absolutely do hope you're right. Sept 19th isn't that far away though.
So in the July 25th PR, they said 'The assigned unblinded statistician team is currently analyzing the Data and the Company aims to submit the amended Study protocol to the FDA shortly thereafter'.
The Aug 16th PR indicates we are now in the 'shortly thereafter' timeframe. unfortunately terms like 'shortly' are relative. Could happen within a few days or shortly can be thought of as several weeks.
When the data access plan was submitted to the FDA for unblinding the 210, it (only) took them 18 calendar days to OK it. If they (FDA) have an idea what the new primary end point may look like it could be a similar timeframe once the new end points are submitted. I'm thinking the timeframe for approval of the amended Study protocol will put us around mid September. Hopefully the DSMB is looking at the updated end points and can have a recommendation ready as to whether to halt and unblind the overall study once the FDA approves. Maybe it will occur around the time that the u-Haul is loaded - say around Sept 19?
They don't give timelines. And we don't know how good the data is except that they can take the next step - to change the primary end point. Until the end point is changed, the DSMB will not publicly weigh in on a recommendation to either continue the trial or halt due to efficacy (hope I spelt that right).
Based on timelines of other drugs currently requesting EUA, we are probably a couple / few months out yet (would love to be proven wrong on that timeline).