This could start the turn around of the PPS. Without tipping her hand, Dr. M has gone from 'hopeful' and 'promising' to "ready for prime time". I would not be surprised to see other companies, like Advaxis, start to advance also, The coming year(s) bode well for cancer sufferers and shareholders. That's a win-win for me.
There was really nothing noteworthy she could have said as the trial is still continuing. Calls for a massive run-up today had no basis in fact. I think some were saying interim results would be released next month but I don't see that happening, either. In this case, the later the interim results the better. Eventually, the science will win out or not. The management has made missteps along the way but that shouldn't impugn the drug. It's all about the outcome of the trial.
I'm guessing "...don't give any information out on drugs in development" means it has NOT been denied. On-going dialogue between Advaxis and FDA still continuing?
Well, wisdom is not normally an attribute I associate myself with but I will say I believe DO went with a higher royalty rate in lieu of upfront cash. How high? We know it's double digits so 10% or above. DO is not stupid and has many shares. I don't think he would screw himself. Us, maybe but not himself. In this instance, I think his interests are aligned with ours. All my own opinion. Wisdom sold separately in finer stores everywhere.
Found this on the FDA site: "The initial frequency of DMC meetings will depend on the expected rate of accrual and event occurrence at the time the trial is designed as well as the perceived risk of the experimental and/or control interventions. Annual meetings may be adequate for some studies; other trials will require more frequent review. Occasionally, there may be a need for extra meetings, when, for example, there is concern about potentially emerging safety problems, or when important new information external to the trial arises. The study protocol will generally describe the schedule of interim analyses to be considered by the DMC, or the considerations that will determine the timing of meetings (e.g., a plan for interim analysis after a certain number of primary outcomes have been reported)."
Good for you.
Is there not a certain time-frame when clinical trial results have to be released (when known by the company)?
Since she is blinded to the data, what exactly can she say? I thought she was just giving a general seminar. I would think anything material would be PR'd first. Is she doing a separate interview?
You are definitely out...out of your mind. Maybe Anavex 2-73 can help you. Let us know how it works out.
Your opinion is as valid as anyone's. I just think DO took a higher royalty rate instead of up-front cash among other things. Once Incontrovertible results come in, DO can get the deals we all know he should be getting so this deal didn't put me off too much..
My thinking was DO got a higher royalty rate instead of up-front cash, plus Knight would know the ins and outs of the fastest way to Canadian approval. Perhaps a race to beat Aduro to market? In the U.S. I think our canine friends will breath a woof of relief pretty soon, too.
Here is a bit of what it says on the FDA site. Check their website for the full explanation: "A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA."
Apparently you can't follow the thread. He was answering a question. Need more help?