We would love to hear your thoughts about our site and services, please take our survey here.
Looks like a concerted effort to undermine or dissuade postings that have provide technical support in favour of Sareum and its molecules. Why anyone who has invested would take offence is rather bizarre. Personally, if someone takes the time to evaluate the science and post data I believe that’s a very generous use of their time. Now when someone continuously posts negativity without any supporting data, you have to question what is the aim.
Utah, if the delay means you can’t start this year, then yes “next year at the earliest is factually correct” but that doesn’t translate too it could be a year away. It could start the first week in January which is a few weeks away.
Morning SOG, might be a stupid theory. But could it simply be the fact that no MTD was reached and this has raised a few eyebrows which in turn has resulted in a request to simply confirm the process and procedures?
From a non-clinical perspective, the most common GNA relate to a lack of information about pivotal safety studies that have been submitted in support of the application and the nature of the contraceptive advice as outlined within the protocol. GNAs are also often raised because of a lack of justification for the starting dose in humans from a safety perspective.
https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-non-clinical#contraception-recommendations
95% chance it will be approved
The Medicines and Healthcare products Regulatory Agency (MHRA) receives more than 1000 clinical trial authorisation (CTA) applications for investigational medicinal products (IMPs) per year. The great majority (up to 95%) of these are approved; however, more than half of all applications require additional information to be submitted before they are considered approvable. Many of the requests for further information or ‘grounds for non-acceptance’ (GNA), are common and are avoidable if available guidance is followed or if a satisfactory justification for not following the applicable guidance is provided in the application.
Clearly Sareum are not alone here. From U.K. gov website
“More than half of all clinical trial authorisation (CTA) applications for investigational medicinal products (IMPs) received by the Medicines and Healthcare products Regulatory Agency (MHRA) require additional information to be submitted before they are considered approvable. ”
So, it’s factual to say the majority of applications have a hick up prior to authorisation.!
Not such a big deal then.
Morning SOG, you certainly appear to have a good grasp of the funding process, many thanks for sharing. What are your thoughts ref the Edison report from Dec 21, extracts below:
“The funding situation has been bolstered with the most recent fund-raising (£1.63m on 16 December) and Sareum estimates the pro forma cash balance (c £6m) to be sufficient to take SDC-1801 through Phase Ia clinical trials and complete preclinical studies for SDC-1802.”
“Sareum will explore initial target indications for SDC-1801. Importantly, the company expects SDC-1801’s clinical development to support the asset’s advancement as a potential treatment for COVID-19-related respiratory symptoms, for which it is seeking funding from the UK government’s AGILE platform/equivalent platforms.”
Do you think it’s likely that the source of funds could be U.K. Gov, there are definitely still trial opportunities available.
https://www.gov.uk/guidance/clinical-platform-trials-for-coronavirus-covid-19-treatments#about-clinical-trials
CoL,
Your statement a couple of days ago:
"After 30 years experience in big pharma and 25 in CMC development, I think some posters need to reestablish a connection to reality. "
Kind of hard to balance when you make sweeping negative statements that don't hold much water. Did you really spend 30 years in big pharma?