Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Will the significant Sony connection give Microsoft confidence or the jitters
Soup it is all guesswork but they have alternatives. Yes they can use the “development “ consultants for advice but it is the bod that makes the decision. They may be considering another non-exec or may consider another agency to try for an exec. So it is right they consider alternatives. If there is a potential partner they may have a requirement, who knows either way, something a bit more permanent would be good.
Yes it is the bad practice that worries me, I was under the impression the first two preclinical tests were done with two separate CROs, not sure now where I got that from. I hope the CRO has provided the bod with the necessary assurance that their protocols are now adequate
The development consultants, see the RNS the company with advice from the “development consultants “ decided to rerun the test of 002 with the same CRO. I would have sacked the incompetent b….s, but there you go. 004 has a pathway, it appears the drug formulation is complete and development will produce something that can either go to preclinical or fast track as the drug will be used for the same purpose. We are getting very little info on 004 so whether decisions are guided hard to say.
From the RNS update 30/5
“In the opinion of the Company and its development advisers”, as an official consultant is Dan a development advisor. There are no operations to oversee, 2 products to develop and sell, with both Jo and Dan as consultants is a full time CEO required, I doubt it.
Blockbuster drugs repurposed are more likely to be approved
https://www.raps.org/news-and-articles/news-articles/2022/5/study-blockbuster-accelerated-approval-drugs-more
Thought this might be of interest it is the FDAs own views on testing repurposed drugs. The speed to market of 004 could be a lot quicker than 002.
“If the new formulation is to be used in a manner similar to previous formulations, the need for additional nonclinical data generally will be limited. However, if the new formulation will be used in a substantially different way (e.g., new route, longer duration), the need for additional nonclinical data becomes greater and additional nonclinical information may be needed even if no change is made in the composition of the formulation. ”
https://www.fda.gov/files/drugs/published/Nonclinical-Safety-Evaluation-of-Reformulated-Drug-Products-and-Products-Intended-for-Administration-by-an-Alternate-Route.pdf
Reformulation…”The loss of 20-year patent term is one of the major factors in the rapid loss of drug sales. This period, called as “patent cliff” also marks the entry of the generic copies of the originator drugs. ”
https://www.iomcworld.org/articles/reformulationfocused-life-cycle-management-of-the-fdaapproved-drugs-53091.html
“We met these time frames in 83% of all office actions mailed in FY 2021 and maintained an average total pendency of 23.3 months, consistent with last fiscal year. Average first action pendency, a traditional pendency metric, increased by over 2 months since last fiscal year, due in large part to side effects of the COVID-19 pandemic ”
https://www.uspto.gov/sites/default/files/documents/USPTOFY21PARSUMMARY.pdf
Is it all over, not yet. “ In the meantime, NHS England has included olaparib on a recently announced list of new drugs which it will be considering making available through the Cancer Drugs Fund, so we’re waiting to see the outcomes of that decision in December.”
https://breastsclinic.com/science-talk-icr-research-takes-a-step-closer-to-patients-as-olaparib-is-assessed-for-nhs/7998/?amp=1
“ AstraZeneca’s ranking will go up to the seventh with $54.5 billion in annual sales in 2028, boosted by sales growth of lung cancer targeted therapy Tagrisso and PARP inhibitor Lynparza.”
http://www.koreabiomed.com/news/articleView.html?idxno=13788
Older it is probably the case AR did say it was an interim position. I also wonder if he is under pressure from family as he was meant to be non exec which suggests there is a lot more activity atm in the role even though it is progressing two products, suggests there is a lot happening behind the scenes.
FFX the minimum requirement for a plc is 2 directors which NFX still has. A large shareholder (if large enough) can express a vote of no confidence and request a meeting to replace a director with a vote of shareholders, it never usually comes to that. It is more than likely he was fed up with the exec role as it was meant to be temporary.
So was he fed up with the exec role or did Lanstead ask him to go, we will never know. Odd we had two separate successful in vivo studies carried out by different suppliers prior to the one where the protocol failed and then produced inconclusive results. Sounds a bit of a mess should imagine there was a bit of dissatisfaction with the largest shareholder over the tone of the announcement. It is the one inconsistent result through a number of tests.