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Sareum Share Chat (SAR)

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Share Price: 0.235Bid: 0.22Ask: 0.25Change: 0.00 (0.00%)No Movement on Sareum
Spread: 0.03Spread as %: 13.64%Open: 0.235High: 0.235Low: 0.235Yesterday’s Close: 0.235


Share Discussion for Sareum


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Thoth2
Posts: 68
Off Topic
Opinion:No Opinion
Price:0.235
RE: Guys
Sun 23:26
I believe the sole agent trial may be combined p1 and 2 in paediatric neuroblastoma. Which could be very interesting...... am waiting for details of the application to be released. Gla
 
Obelix
Posts: 8,977
Off Topic
Opinion:No Opinion
Price:0.235
Guys
Sun 21:54
It's possible We get a re-rate after approval?
Num4
Posts: 623
Off Topic
Opinion:Strong Buy
Price:0.235
Breakthrough Therapy
Sat 20:50
On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation. A breakthrough therapy is a drug:
intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.

http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm

another timescale to pin our hopes on, 60days. Wonder if Tim/CRT requested breakthrough therapy - they have the evidence and fulfill the requirements.
estar98
Posts: 5
Off Topic
Opinion:No Opinion
Price:0.235
CTA response - 30 days
Sat 12:18
I think 30days should be the case, I agree there is no way for healthy volunteer for chemo therapy, this means the phase 1 result will show certain efficacy indications.
Hopkirk
Posts: 1,353
Off Topic
Opinion:Strong Buy
Price:0.235
CTA response - 30 days
Fri 17:24
Sorry Thoth but i think its 30 days. Type A trials are low risk so CHK1 will be type B or C (first in human and oncology drugs tend to be risky). Also there won't be any healthy volunteers (as there is no chance that healthy people will be given CHK1 or chemotherapy).

So this part is more relevant...

The initial assessment will be completed within 30 days of being submitted. Applications for healthy volunteer trials and sponsor-determined phase I trials in non-oncology patients may qualify for a shortened assessment time (average 14 days). You should state on your covering letter if you think your trial is eligible

GLA

https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#when-a-clinical-trial-authorisation-cta-is-needed
Thoth2
Posts: 68
Off Topic
Opinion:No Opinion
Price:0.235
CTA response- 2 weeks
Fri 15:42
For certain Type A trials, the Clinical Trial Notification SchemeLink open in a new window pages of the MHRA web site describe the process and timelines for the CTA application. Once the application is sent to the MHRA, it will be acknowledged with an accompanying note to say that the trial may go ahead after 14 days from receipt of notification if no objections have been raised. The acknowledgement letter will act as the authorisation.
For Type B and C trials, the notification scheme is not applicable and each application will be fully assessed by the MHRA. They will provide an initial response within 30 days of receipt of a valid application, with an average of 14 days for Phase 1 healthy volunteer studies. The MHRA CTA PageLink open in a new window lists the documents required for a valid application.
estar98
Posts: 5
Off Topic
Opinion:No Opinion
Price:0.235
check1 CTA response time
Fri 15:12
anyone knows the check1 CTA response time, is it 6 weeks or 16 weeks from submitting the CTA? Thanks
gige
Posts: 4,633
Premium Chat Member
Off Topic
Opinion:No Opinion
Price:0.235
sar
Fri 12:42
A nasty illness ,where we can give no help to anyone ..If Sar can come up with something good ,,,,,,,,,,,,,,,,,,We will fly to the moon ..
SHAT2
Posts: 248
Observation
Opinion:Strong Buy
Price:0.235
Morning every one.
Fri 09:38
I lost my sister to cancer she had breast cancer she was 56 a lovely beautiful person. So i pray to god that these compounds work not because of the money but it will help because i know what cancer can do to people its a unforgiving disease it kill's any one. I do believe sareum have got compounds that work C.R.T know that to! That's why they are pumping money into this and giving sareum millstone payments to. They would not being doing that on a compound that did't work. This is going to be very big this could be as big as penicillin time will tell. IMOP GLA.
Obelix
Posts: 8,977
Off Topic
Opinion:No Opinion
Price:0.235
Guys
Fri 09:07
Good morning to all here.
I'm sorry to hear that you Guys lost someone close to You with this bad disease. I lost my Grandmother as well with Cancer.
I hope this new Guys (drugs and new compounds) can save life's when they are diagnostic with this Terrible Disease.
I believe SAR will be one of the new compound that can help people to combat Cancer.
The next few days & weeks will be important for us here, may be another good RNS about the other compound and approval by Gov. to start the trial.
Let's see Guys, have a nice day all here, off to Uni.
Obelix




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