Member Info for Bobbler

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?

Evening all,

I’m arranging a charity event and would appreciate any spare trumpets, CoL has worn his out and is in desperate need of a replacement.

Sneckieboy , you really are a no mark. Guessing mummy didn’t pay you enough attention as a child and your dad was embarrassed by you……sad really

Utah, out of interest, why would you be buying?
By your own reckoning if it drops to 50p they still won’t have anything licensed or in trials. Struggle to see the logic in that Pearl of wisdom

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.

Ref Consolidation, it was approved by the majority of share holders….. so clearly enough people agreed with the suggestion.

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, 30+ years, and a keen nose for trumpet players who claim to be so knowledgeable but make basic errors.

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?

B7- fair point :-)

No I don’t, please explain

JJ, is that supposed to make any sense? Guessing you are short of a few chromosomes.

Colbalt, Are you serious? More suckers? According to you over the past, god knows how many months, anyone who has been consistently positive about SAR has been a delusional clown. I have to say you really are turncoat of the highest order, actually you are in fact an Uber **** womble.

https://www.fiercebiotech.com/biotech/bms-sets-sights-phase-3-lupus-trial-tyk2-inhibitor-year-after-positive-readout

Good morning SOG, thank you for the very logical response.

Is it fair to assume as we are very close to the start of November, and to be so confident they will start clinical trials this year intimates they have already received a green light ref CTA, just awaiting official sign off?

Promises of hibernation! Now that’s something to get excited about.