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I was surprised by todays trading, but tend to agree that it was triggered by the Edison article. I would though expect recovery and a move back into a rise. We have sufficient funds for the current trial. We probably have more cash coming from 737, Edison's coverage might result in more HNWI investments, or we do a raise. If we raise to progress deeper into trials this will ultimately increase returns. IMO a temporary dip which I think will quickly be recovered and past. GLA
Exciting times ahead of us now that we are in clinic. I hope that we will receive timely updates on progress. Alongside that news on 737 with some FOMO and perhaps belief that an 1801 deal will be agreed before the end of trial. Will hopefully see this SP moving upwards. I'm not a chartist but commentary in that space also seems positive and I do wonder if PH may finally deliver II's now that we are in clinic. GLA
HBD, I understand your thought process, I am though interested to see the outcome when we get to the date. As I understand the Bard release is in beta at the moment it could therefore have bugs which could include accessing things that in its final version it may not eventually have access to or release in its findings.
In terms of will they respond I think it is possible see below for an extract from an HREC terms of reference, for a researcher or other visitor to apply the agenda's must be available in advance.
Observers to the Meeting
The HREC welcomes the attendance of investigators and other visitors as observers to its meetings. Anyone
wishing to attend a meeting of the HREC as an observer is required to notify the HREC Manager of their
request in advance and in writing. The HREC Manager will discuss the request with the Chair before
approval is granted for the visitor in question. All visitors to a HREC meeting will be asked to sign a
Confidentiality form prior to attendance at the meeting and will be provided with a set of papers at the
meeting which must be returned to the HREC Manager at the conclusion of the meeting. The attendance of
visitors is noted on the minutes of the relevant HREC meeting.
Decisions at meetings must be made following an exchange of opinions from each of the members who
constitute the minimum membership, whether at a face to face meeting, by teleconference or
videoconference or where one of those members is absent, by the receipt and consideration of the
member’s views.
The HREC will endeavour to reach decisions by general agreement, which need not involve unanimity.
The HREC will record decisions about approval, amendment or rejection of proposals in written or electronic
form, with reasons for those decisions linked to the relevant sections, chapters or paragraphs of the National
Statement.
The members of the committee will undertake their work in accordance with relevant RMH policies, including
the Royal Melbourne Hospital Values and Code of Conduct.
HBD no response to me email overnight, I will share however if they give a response, can see your view on risk definition though I wonder if they will have a triage process for categorisation and balance their view to smooth volume in any given meeting based on relative risk. These AI s do though throw up interesting results, the HREC it included seems logical as a location. I will continue searching with it on topics to see if anything crops up and for me own personal satisfaction on their quality of result rub across multiple days to understand consistency. GLA
HBD I did see the timetable you found previously, however it is caveats with 'ALL NEW HIGH RISK SUBMISSIONS ARE DUE BY 4:30PM OF THE CLOSING
DATE. LOW RISK SUBMISSIONS DO NOT PERTAIN TO THIS SCHEDULE' if we are low risk we could be in a differing schedule eg alternate weds for low and high risk. If they respond to my email then we will know GLA
Don't disagree that search results have to be treated with skepticism, however I did do a standard Google search on the other notes and they check out. Not sure of the nuances of these meetings perhaps that have to reach a preset quorum so this represents a placeholder for an attendee yet to confirm their attendance?
Aber
This search result is interesting again from Google Bard
Search : What hrec meeting will review the ctn application for sareum sdc1801
The HREC meeting that will review the CTN application for Sareum SDC1801 is the 2023-05-10 meeting. The meeting will be held at 10:00 AM in Building 1, Room 101. The meeting will be chaired by Dr. John Smith, and the panelists will be Dr. Jane Doe, Dr. Peter Jones, and Dr. Mary Green. The meeting will be open to the public, and anyone who wishes to attend is welcome to do so.
The HREC is a committee that is responsible for reviewing and approving clinical trials. The HREC ensures that clinical trials are conducted in a safe and ethical manner. The HREC will review the CTN application for Sareum SDC1801 to make sure that the trial is safe and ethical. If the HREC approves the trial, it will be conducted in accordance with the HREC's guidelines.
If you are interested in attending the HREC meeting to review the CTN application for Sareum SDC1801, please contact the HREC office at (03) 9035 5555.
Continuing to play with AI searches including the question this time. Good to see SAR are getting more formalities in place.
Search criteria : Where have sareum applied for BLA
Sareum Holdings PLC has applied for a Biologics License Application (BLA) for its TYK2/JAK1 inhibitor SDC-1801 in the United States and Europe. The company expects to submit BLAs for other markets, including Australia, in the coming months.
Here are the details of the BLA applications:
United States: Sareum submitted a BLA to the U.S. Food and Drug Administration (FDA) for SDC-1801 in February 2023. The FDA is expected to make a decision on the BLA in the second half of 2023.
Europe: Sareum submitted a BLA to the European Medicines Agency (EMA) for SDC-1801 in March 2023. The EMA is expected to make a decision on the BLA in the first half of 2024.
Australia: Sareum plans to submit a BLA to the Therapeutic Goods Administration (TGA) for SDC-1801 in the second quarter of 2023. The TGA is expected to make a decision on the BLA in the second half of 2023.
GLA
HBD, for Bard to respond with this it must have found it somewhere, I agree that they do not always get context, also I did not put a time range in my question. The language read very much like a media release in style with some quite precise comments. GLA
I have been running searches using the new AI search engines and have received a strange result. Does anyone have a view on if this is old or could the BOD be progressing in this way under the radar. I do note that the result talks about 'SDC18021' views appreciated
'Yes, Sareum SDC18021 has received clinical trial approval in Australia. The Therapeutic Goods Administration (TGA) granted the company a provisional approval for a Phase 1 clinical trial of the drug in patients with advanced solid tumors. The trial will assess the safety and tolerability of Sareum SDC18021 in patients with advanced solid tumors, as well as its preliminary efficacy.
Sareum SDC18021 is a novel antibody-drug conjugate (ADC) that targets the cancer-associated protein CD73. CD73 is expressed on many types of cancer cells, and it is thought to play a role in cancer progression. Sareum SDC18021 is designed to bind to CD73 and deliver a potent chemotherapy drug to cancer cells.
The Phase 1 clinical trial of Sareum SDC18021 is expected to enroll up to 60 patients with advanced solid tumors. The trial will be conducted at multiple sites in Australia. The primary endpoint of the trial is to assess the safety and tolerability of Sareum SDC18021. Secondary endpoints of the trial will include the preliminary efficacy of Sareum SDC18021 and its pharmacodynamics.
The results of the Phase 1 clinical trial of Sareum SDC18021 will help to determine the safety and efficacy of the drug in patients with advanced solid tumors. If the drug is found to be safe and effective, it could be developed for further clinical development and potential approval for use in patients with cancer.'