Member Info for daveycaferacer

I agree with all those points Jatw, that's a great summary of the state of play

The last point is particularly interesting

The Company is certainly on track and achieved all its main stated objectives in 2020, apart from the desire to acquire a large molecule asset. I hope we hear more on that front shortly. $20bn mcap by 2025 is certainly achievable if the pipeline delivers as predicted without regulatory delays, and Savo is approved ex-China.

Happy new year to all posters/shareholders who use this very informative bulletin board.

For any who do not think Tiziana is under-valued take a look at Puretech, currently just over £1bn mcap

https://www.puretechhealth.com/programs/wholly-owned-pipeline

They have a much smaller pipeline than Tiziana, although they have had a small amount of collab revenue in the last 12 months. Currently owned by a number of FTSE All Share Trackers, which is something I hope happens to Tiziana following the Main Listing.

"Trading is closed on Monday"

That is not correct - NASDAQ, the LSE and NYSE are all open for trading as usual

January 2021

The big issue with Lilly appears to be their lack of interest due to a competing drug. We can now look forward to pancreatic NET indication being approved shortly too, together with approval in the United States. On the latter, the Co's website continues to add a raft of new positions in the U.S. including analytics, regulatory and sales roles. 2021 will be transformational.

Many virologists, immunologists, and epidemiologists have said that antibody therapeutics will be needed going forward. People who think that getting a population vaccinated will result in getting back to normal by mid 2021 will be disappointed. Covid in one form or another is here to stay forever in one form or another.

Hopefully approval for the use of Sulanda for the treatment of pancreatic NET will follow in H1 2021

Yet again the Company delivers on its promises, this time with the approval for Sulanda for non pancreatic NET. It will be interesting to see if it is included in the new NRDL which is due any day now.

Mush like previous years, we've had feasibility studies, MOU's, assessments of "shovel ready" Projects and heads of terms & NDA's but nothing has been delivered to add shareholder value. Hopefully 2021 will change that situation although somehow i doubt it.

It's nice to see some coverage in one of the leading industry journals (subscription reqd)

https://www.thepharmaletter.com/article/chi-med-begins-rolling-surufatinib-submission-in-usa?mc_cid=88411d05d8&mc_eid=6b5f0b8b96

Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

– Company plans to complete rolling submission in the first half of 2021 –
– The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio –
– The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by 51%, extending PFS of pancreatic NET patients with an acceptable risk/benefit ratio –
– First NDA submission by Chi-Med in the United States –

Hong Kong, Shanghai, & Florham Park, NJ: Monday, December 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has initiated the filing of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) – the first portion of a rolling submission for surufatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”). Chi-Med plans to complete the NDA submission in the first half of 2021, which would be the company’s first NDA in the U.S.

The Fast Track Designation granted earlier this year by the FDA permits the company to submit sections of the NDA on a rolling basis. The NDA is supported by data from the two positive Phase III studies of surufatinib in NET in China, along with data from surufatinib studies in U.S. non-pancreatic and pancreatic NET patients. The company previously announced that it had reached an agreement with the FDA during a pre-NDA meeting, whereby these studies may serve as the basis to support an NDA submission. Filing acceptance of the NDA is subject to FDA review of the complete application. The data package will also be used to file a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in 2021, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Marek Kania, M.D., Managing Director and Chief Medical Officer of Hutchison MediPharma International, said, “With the initiation of our first regulatory filing in the U.S., we are executing our strategy of building a global pharmaceutical company that brings innovative cancer therapies to patients worldwide. There is a great need for additional therapies to treat neuroendocrine tumors, and surufatinib has demonstrated significant clinical benefit in patients with advanced tumors. The NDA filing to the U.S. FDA represents a significant step toward our goal of commercializing surufatinib and other novel therapies globally.”

The company plans to initiate an Expanded Access Protocol to ensure patients with limited therapeutic options have access to this important treatment. Enrollment into this early access program is anticipated to begin in the first quarter of 2021, once regulatory clearance of the protocol has been granted by the FDA.

That's a good question, given the urgency I am not sure how the FDA would view the next step really, probably dose expansion into a much bigger cohort. The Company will need to get guidance from the FDA, especially if the results are positive.

yes, and looking forward to the following in the next month:-
1. Brazil interim covid trial data
2. Main Listing
3. Accustem listing
4. More specialist Broker coverage and Analyst target updates

Further coverage on the importance of the us of antibodies in the fight against coronavirus

https://www.dailymail.co.uk/news/article-9088217/British-scientists-trial-new-Covid-antibody-therapy-patients-INSTANT-immunity.html

January 2021 will be transformational for the Company:-

1. Accustem listing
2. Main Market listing
3. Brazil Covid trials initial data set & update on next steps

NASDAQ Closes 13:00 EST / 18:00 GMT today

yes, if nasal administration of antibodies proves to be effective, outside of Foralumab, the technology IP is owned by Tiziana and will be very significant indeed

Up 14% doesn't disappoint me

the question is the efficacy, which could be anything between 0% and 100% but whatever it is, the scientific and medical communities think a therapeutic antibody treatment will still be needed.

the NDRL update is very late this year, I do hope we get Surufatinib approved, getting on the list at the same time as approval however is a tall order - I am not sure if that has happened to any other drugs in the past.