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Https://twitter.com/tmsreach/status/1664672451639246867?s=12&t=VnE8Kx_V2THDh00_814JJw
Grounds for imposition of clinical hold:
The grounds for imposition of clinical hold for a proposed or ongoing Phase 1 investigation include the following:
Human subjects are or would be exposed to an unreasonable and significant risk of illness or injury; or
The clinical investigators named in the IND are not qualified by reason of their scientific training and experience to conduct the investigation described in the IND; or
The investigator brochure is misleading, erroneous, or materially incomplete; or
The IND application does not contain sufficient information needed to assess the risks to subjects of the proposed studies; or
The IND application is for the study of an investigational drug intended to treat a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of a risk of reproductive toxicity (i.e., affecting reproductive organs) or developmental toxicity (i.e., affecting potential offspring).
However, this criterion does not apply to circumstances when: (1) proposed studies are pertinent only to one gender, (2) proposed studies are conducted in subjects who do not have the disease or condition for which the drug is being studied (e.g., some studies in healthy volunteers), (3) another study that does not exclude members of the other gender with reproductive potential is being conducted concurrently, has been conducted, or will take place with the same investigational product within a reasonable time agreed upon by FDA.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold
Think this is meant for PURP ...
They dont know what they are yet, letter to follow in 30 days
Welcome to the mad house L!
He needs 20p for an invite now he has sold half !
The board have decided that for the years of hard work Dr Vlad gets to buy at par with the market… I’ve really heard it all now. ROLL ON PHASE 1 !
Fast Track designation requests can be submitted at any time during the drug development process, ideally no later than the pre-BLA or pre-NDA meeting. However, to receive the full benefits of the program, Scendea recommends that requests are submitted as early as possible in the drug development process (based on the availability of data required for the request), such as at the time of the initial IND submission. If the request is submitted after this time, Sponsors should note that requests must be filed as an IND amendment. Requests for Fast Track designation are submitted to Module 1, Section 1.7.1 “Fast track designation request” of the IND. As all submissions to an IND remain confidential, the FDA does not disclose Fast Track submissions or decisions, unless the submission has been publicly disclosed by the Sponsor.
FDA will review the request and decide within sixty days whether the drug meets the criteria for Fast Track designation. If the product is designated, a designation letter will be sent to the Sponsor outlining that Fast Track designation has been granted and that the development program must continue to meet the criteria for designation moving forward. If the Agency determines that a Fast Track designation request was incomplete or that the drug development program failed to meet the criteria for Fast Track designation, the Agency will send a non-designation letter to the Sponsor. The non-designation letter will state that fast track designation is not granted and explain the reasons for the Agency’s decision.
No word on telegram! Was a shame to see you go from Gold’s group it was how I first heard about HEMO! We are all still there waiting - would be great to get you back.
We have US Labour Day as well so that’s another day the FDA lose !
Https://www.fca.org.uk/publication/data/short-positions-daily-update.xlsx
Hi all, found something I think may be of interest. If you skip to the conflict disclosures of Dr Saar Gill, our friend at Penn, you can see he has declared consulting fees from J&J. I recently read some speculation that they may be our CAR-T trial partner. Does anyone know the rationale behind this ? Have we previously established a connection between J&J and HEMO or a close link of HEMO? I should add - my question is in relation to CAR-T. I am aware of the previous collab on the lupus treatment.
https://general.kaznmu.edu.kz/wp-content/uploads/2014/02/Welhausen-2022-CRISPR-CAS-Engineered-T-cells-for-cancer-immunotherapy.pdf
On a side note - Dr Gill also declares a conflict with Interius. They have just done a deal with our friends at WuXi
https://www.prnewswire.com/news-releases/interius-biotherapeutics-announces-successful-manufacturing-partnership-with-wuxi-advanced-therapies-301818745.html
Final Results for the Year Ended 31 December 2022 --- 28. Subsequent Events
"The Company has entered into a preliminary agreement with a service provider that it is anticipated will project manage and supervise the running of Phase I clinical trials for its HEMO-CAR-T cell therapy, subject to negotiation of a Master Services Agreement."