RE:RE:RE:RE:RE:RE:Advisor Group Holdings First off there is only one CRO, ppd, so you are misunderstanding that term. The CRO is the company employed by thtx to manage the trial. It is not the individual clinical sites, there isn't "this CRO" and "that CRO".
I still don't understand why you keep mentioning the expanded access program in relation to a possible expansion into Europe of the trial. Expanded access is something completely separate from the trial and as the company has said they are not at the stage to offer that in oncology. Honestly forget about expanded access for now it's of no relevance atm.
They have been expanding the number of clinical sites in the US so far to keep up with the pace of enrolment. When they move into part 2, called the expansion phase, the enrolment rate needs to increase again. Their plan seems to be to expand into more US clinical sites and Europe. That probably requires an IND with the EMA before they open any E.U. sites. It sounds like that will happen to coincide with part 2 so no they are not in Europe now. This might be about the positive outlook of the trial. It might be they have one eye on how Covid is shaping up in the US and fear a new lockdown in the US slowing enrolment, it would be prudent to have a back-up plan for that. It might just be they have an eye on the future approval process with the EMA. It might be they got such a positive outcome with the FDA why not try repeat that now with the EMA. It looks mostly positive and it looks like it might happen for the start of part2. I assume it will still be considered a single global trial and it would be managed globally by PPD.
From a practical perspective it seems pretty simple, I'm not sure why you are fretting about this. I don't think it significantly increases costs to the point we have to concern ourselves about where the extra cash is coming from.
scarlet1967 wrote: Of course absent clarification we can only speculate, absent toxicity they should be well above Docetaxel's therapeutic window which by the way it can start at lower dosages than 100mg/m2 because of adverse effects. Point is they know much more than they are happy to share and based on their language it's positive so far, they need few more months to do the CT scans, blood tests etc before they can announce their findings and I get it but what I don't get is the low profile for instance they could say we have dosed a number of patients thus far few in this CRO and few in that CRO etc. Build up some excitement around the protocol so investors get motivated and stop selling their shares, looking for next exciting announcement. They seem to be doing that with individual investors but nothing on the retail front . If they want favourable market conditions they need to lessen up a bit and feed the market with few hints re their progresses.
palinc2000 wrote: The price at which they draw under the ATM will be very revealing ......Even though we will only have access to the volume and price after the facts it will be a good test to see if the walk matched the talk when the drawdows were made.
Contrary to most my opinion is that they have identified a specific need for the use of proceeds under the ATM and it is not just a stand by facility.
Are they expecting market conditions to be more favorable in the weeks monhs to come? I sure hope so !
scarlet1967 wrote: I still believe the ATM was a strategic decision, reason is they don't need the money now however if they approach a partner for NASH not having the funds to start the futility analysis at the same time fund their oncology program doesn't put them in a position of "strength". I also believe based on the data from oncology trial under expanded access program they could file an IND in Europe for oncology. Usually it's won't be early during process but if data is great who knows maybe they will start it earlier. I think the company wanted to secure more funds earlier rather than later to keep its options open for their next move in both programs.
SPCEO1 wrote: I spoke with Bucknelly recently and he mentioned the company had told him they had no intention of utilizing the ATM at this time. So, unless he didn't hear what they said correctly, I think it is good news.
palinc2000 wrote: We dont know if thse were purchased under the ATM .... if not then its good news