Member Info for Mars1

Rob Davis from Merck
“And so, the final thing is that, we are doing lots of things in relationship to extending the reach of Keytruda and not just Keytruda, Lynparza, Lynparza for that future. But I’ll just give basic — I was asked this question, do you like dosing changes? Do you like frequency of coming in? Do you like devices? Do you like formulation? And I sat there, and I said, why should I choose. We want to do all of those, because that’s important for the patient population.”
https://tradetoday.co.in/merck-co-inc-mrk-ceo-rob-davis-presents-at-the-goldman-sachs-43rd-annual-global-healthcare-conference-transcript/

“Key players in the global polypill products market are engaged in regulatory approvals, technologically advanced products, launch of new products, and acquisition & collaborative agreements with other companies. These strategies are aimed at addressing unmet needs in the market, strengthening the product portfolio, and investing in research ”
https://voiceofthesouth.com.au/2022/06/20/polypill-products-market-global-share-market-size-growth-size-opportunities-trends-regional-overview-leading-company-analysis-and-key-country-forecast-2022-2031/

Despite the sp the growth of PARP inhibitors is estimated at 73% CGAR, key players AZ and Merck.
https://indiandefencenews.info/61025/uncategorized/parp-inhibitors-for-cancer-market-growing-at-a-cagr-73-0-key-player-astrazeneca-tesaro-merck-co-clovis-oncology-pfizer/

Bit of a coincidence it is just below the 3% holding notification when taxes added. Someone wants a holding but atm does not want a named listing either a precursor to a bid or a long term commitment in support

Each 1% reduction has to be notified so it is one sell. Most we have seen is 1m a day, even 7m is 1%. So they have done a private deal.

So where did they go, 20.9m we haven’t seen that volume of sales, so was it private. Someone has bought just under the 3% notification , a client of Lanstead or someone wanting a partnership holding?

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.

Not too worried about the two consultants because they have a skinful and have eyes on the target. The bod has the final say unlikely that Jo and Dan would want different directions.

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

RNS
“ The Company has previously demonstrated the enhanced performance of NXP004 compared to olaparib's free form.”

Thought it was recent ie 8 hours not so apologies

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