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My understanding is that a drug can be preliminarily approved at the end of Ph2 in exceptional circumstances (Fast Track) and a Ph3 then conducted in parallel to marketing, for complete data and full approval!?
If any informal offer is verbally knocked back, then the interested party can make it formal tif they wish to force the CEO's hand. That is not a good way to takeover a company. Most BO's are "friendly" and not many hostile bids, so it's in the interests of both parties to agree a way forward.
DTW,
A couple of comments:
-The preferred candidate could be an external consultant already working for AS for sometime, they just making it a permanent post.
-I think AS and EF said at the AGM that there is a lot of interest in the technology. No bids or interest declared publicly, but that doesn't mean there hasn't been any. Rumour has it that AS knocked back an informal bid of ca £9.
-I think any interested parties will be waiting on Ph1a peer reviewed results, which maybe not available til next year, depending on whether cohort 7 goes ahead or not, given that they say that they need to collate and review the results and conclude the design (+approval) for Ph1b.
So all in all a waiting game, but big things will happen in less than 6 maths, imo.
Donkey, it is not yet appropriate to "shout it from the roof tops" as they have still not completed Ph1a, when they do and have analysed the data then they will publish it for peer review. The PR show is unlikely til then, IMO!
On completion of Ph1a they have to collate and review the data internally and only then release it for peer review. Also AS said that there would be likely 2 months after trial completion to review the data and plan/get approval for the protocols for Ph1b. SO unfortunately the release of full data to the public may not be for 3mths, possibly after start of Ph1b.
However I do expect a punchy statement at completion of Ph1a with some basic details.
RAH. You may well be right that AS will know the efficacy as per your timings, BUT will he share it with us PI’s, I doubt it, so the only impact would be on third party negotiations! I doubt the market/sp would respond until informed by an rns.
I don't think these initiatives will create much short term stimulus to Avct, maybe by next year!
Also AS will not make mega statements and major PR push til at least Ph1a results (especially with the new design) and more not fully expansive til someway through Ph1b (and then maybe only when concluded, unfortunately) as AS is a scientist and is by nature cautious and will be guided by peer review and solid statistical proven data! 6 positive biopsies is a very good indicator of success, but not enough proof as yet!
The only reason TD have not updated their CoS, imo, is that they are waiting on Ph1a completion report so they can base any change on written fact rather than an assessment of progress of cohorts success to date! They are being somewhat lily livered!!
Bella,
Yes I think that is the sort of partner that avct need to get Ava6000 to market (if they want to keep it in house) and I think they require to do so this year as the lead time must be min 12 months to do TT and set up, trial runs, approvals, etc.
Mr Ripley,
The only excuse for not revealing the forward the plan would be that it is a flexible plan with many options! haha
Maybe that the new Ph1a protocol (not yet approved) has changed the original plan somewhat. The financial plan might be flexible due to uncertainty of what they can achieve, from licensing 3996 to Partnering for 6000 and all things in between. Also they will not want to declare much of this due to negotiating sensitivities.
I am frustrated as anyone about lack of clarity, and only hope that it is because there are too many balls up (not literally!) in the air at the moment!
BITL,
The main reason for limited comms on commercial matters is that regulators do not look kindly on companies commenting on trials until they are concluded, so have to wait til end Ph1a for big reveal imo!
However plenty other news due in next month or so, Ph1a new protocol, and AACR .