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Please supply the names of CEO's who turned down the invitation.
Another job filled. Three left.
Do we know who else was there?
"...now witness our ceo standing behind the president..i believe.."
He is indeed...
Wow! Is there an article that goes with this?
Thanks, Catt!
CATTDOGG, can you share anything you talked about on your call to IR? Thanks!
No idea, other than everyone and their mother are filing lawsuits. The last conference call I heard sounded actually positive.
Anyone still alive here?
Cat,
Was it an informative call? Obviously, they can't give out much or any new info but would you call it a positive call? Thanks!
Why don't you investigate and get back to us. Let us know your findings.
Can't seem to find a PR so maybe it was an internal promotion?
I believe they do.
" In limited circumstances, the Agency may agree that a specific finding (e.g., a particular p value on the primary efficacy endpoint) of a study will satisfy a specific objective (e.g., demonstration of efficacy) or support an approval decision."
That is what most of us are hoping for!
I don't know if the SPA is available to the public. You'd have to comb the FDA site for that info. The SPA does not, in itself, guarantee an approval, rather it is a set of protocol agreements that may, if the results of the trial allow, be used as a basis of approval.
"A special protocol assessment can document the Agency's agreement that the design and planned analysis of a study adequately address
objectives in support of a regulatory submission. A special protocol assessment can also identify questions raised by the sponsor to which the Agency is unable to respond. In limited circumstances, the Agency may agree that a specific finding (e.g., a particular p value on the primary efficacy endpoint) of a study will satisfy a specific objective (e.g., demonstration of efficacy) or support an approval decision. However, final determinations are made after a complete review of a marketing application and are based on the entire data in the application."
"SPA is a process in which sponsors may request to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials..."
So, no, it does not guarantee approval but it does address agreed to items (size of the trial, endpoints, etc.) which, if met, can set the basis for approval. In this trial, then, size is not an issue.
"The Ph 3 trial we have going is rather small. Other drugs that scored well have been rejected on the basis of size alone.
And there is no solid assurance that we can pass a Ph3 trial acceptable to the FDA...Many drugs look good till the Ph3 results face FDA approval."
Since we have an SPA for the PIII, I'm not sure I understand the relevance of this part of your post.
Now, if AXAL was combined with this...
Add to that our own unnecessary hold and, yep, we're well behind where we should be now. Like you, hopeful but aware it may be a while before we start to see our true value potential.
Was there another clinical hold after the H&N one was lifted in November?
Well, of course, the NDA has to be filed before any approval could be considered. If efficacy and safety are better than SOC, I think we have a decent chance.
If the news was bad, I truly think it would have been announced today after hours or, trading halted on Monday, and then announced. Instead, we get a PR stating results will be announced before the market opening on Monday. I don't think they would make a point of a PR now if it wasn't good. Of course I could be wrong (would hardly be the first time) but it makes no sense to broadcast what would be bad news right now. I was hoping for $10 if the news is good but I'll certainly take $20! I have some options so my downside is limited but up my upside might be great. Anyone else have thoughts on this?
I guess I got Monday!
I'd prefer Monday. Friday is the traditional "bad news" day.
Use link below and search for key words from there.
https://endpts.com/
Is the GOG PII still ongoing? I thought it was stopped when the PIII started. The clinicaltrials.gov page hasn't been updated in a year.
https://www.clinicaltrials.gov/ct2/show/NCT01266460
For what were we watching?
Congrats on that decision! I wish had made the same one.
And you base this on...?
June. Expiration is after ASCO, so I feel reasonably optimistic it will be at or above $1. I'm sure AF will attempt a hit piece around that time so who knows, really.
Analysis? I was simply hazarding a guess. I think having an oral presentation at ASCO may keep the price up as well as the impending NDA. Could it drop back to the .50's? This is biotech, anything can happen. I bought $1 calls at .05 so I like my risk to reward ratio.
I'll hazard a guess and say probably not.
You have all of two posts on this board. What is your rational for not buying?
As they say, there is no such thing as bad publicity.
DOC communicates his passion pretty well here. Great video!
James' timing may be off but I still believe there is a deal in the works, just a matter of time. Having an agreement in place before the MAA submission would help speed things along, I believe. Based on this statement, it appears to have been partially filed, “EMA’s issuance of this certification is a major milestone for Advaxis,” said Daniel J. O’Connor, President and CEO. “With a significant portion of the MAA now reviewed and certified, we are preparing to file the complete MAA as we work to bring this innovative immunotherapy to patients with metastatic cervical cancer who have limited treatment options.”
BTW, PM received, thanks.
Try early May (top of page 4).
https://www.sec.gov/Archives/edgar/data/1113423/000104746917002609/a2231781zf-3a.htm
When you add the hold combined with very sick patients, I agree. Hopefully, that won't happen again. A needless hold that may have contributed to more deaths the AVXL ever could.
For the GOG study,
"Median OS >1 year and 12-month survival of 55.6% in 69% patients given all 3 doses."
So, increasing the number of doses seems to improve the outcome.
For the anal cancer study, "Expected CR rate at 6 months ~50%; 90% 6-month CR rate in this study (9 of 10 treated patients."
As the treatment is "tweaked" I expect we'll see continued improvements in efficacy, especially when used in combination treatments. i remain cautiously optimistic about the future of Advaxis.
I think we standout by comparison.