Lets do the formal side first, shall we:
Office in Ireland:
https://www.registeracompanyinireland.com/contact/
Your comment at the time:
"And, what's the go with the Ireland office? Are shareholders aware that KK has a holiday home now?"Current
Submit
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21 USC 360cc: Protection for drugs for rare diseases or conditions
Text contains those laws in effect on May 22, 2025
From Title 21-FOOD AND DRUGS
CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V-DRUGS AND DEVICES
Part B-Drugs for Rare Diseases or Conditions
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§360cc. Protection for drugs for rare diseases or conditions
(a) Exclusive approval, certification, or license
Except as provided in subsection (b), if the Secretary-
(1) approves an application filed pursuant to section 355 of this title, or
(2) issues a license under section 262 of title 42 for a drug designated under section 360bb of this title for a rare disease or condition, the Secretary may not approve another application under section 355 of this title or issue another license under section 262 of title 42 for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2) 1 of this title does not apply to the refusal to approve an application under the preceding sentence.
(b) Exceptions
During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if-
(1) the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or
(2) the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.
(c) Condition of clinical superiority
(1) In general
If a sponsor of a drug that is designated under section 360bb of this title and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.
(2) Definition
For purposes of paragraph (1), the term "clinically superior" with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.
(3) Applicability
This subsection applies to any drug designated under section 360bb of this title for which an application was approved under section 355 of this title or licensed under section 262 of title 42 after August 18, 2017, regardless of the date on which such drug was designated under section 360bb of this title.
(d) Regulations
The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on August 18, 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.
(e) Demonstration of clinical superiority standard
To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary-
(1) upon the designation of any drug under section 360bb of this title, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and
(2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.
(June 25, 1938, ch. 675, §527, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2050 ; amended Pub. L. 98–417, title I, §102(b)(6), Sept. 24, 1984, 98 Stat. 1593 ; Pub. L. 99–91, §§2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387 , 388; Pub. L. 103–80, §3(v), Aug. 13, 1993, 107 Stat. 778 ; Pub. L. 105–115, title I, §125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326 ; Pub. L. 107–281, §4, Nov. 6, 2002, 116 Stat. 1993 ; Pub. L. 115–52, title VI, §607(a), Aug. 18, 2017, 131 Stat. 1049 ; Pub. L. 116–260, div. BB, title III, §323, Dec. 27, 2020, 134 Stat. 2933 .
https://uscode.house.gov/view.xhtml?req=(title:21%20section:360cc%20edition
relim)
Looking at the above, I see quite a few parts there that would/could (we will see and compare it with the data available in THAT indication, being ADULTS with HR-AGVHD) make the Cynata statement correct, I.e. same drug, same in indication, clinical superiority, etc.
Oh but but but MSB owns MSCs, all MSCs, blablabla.
Why do you think Cynata has had their fingers in so many published papers now highlighting the differences of MSCs? "Same drug"?
A shout out to Margeaux Hodgson-Garms at this point. Thank you for your ongoing contributions.
Therefore, I refer to the above image.
You keep going on about the Phase 3 trial statement. OK, show me a statement from the FDA that a P3 trial is a legal requirement in every indication.
Let me safe you the time:
https://www.sciencedirect.com/science/article/abs/pii/S1535610824003532#:~:text=shortening%20development%20timelines.-,1,duration%20of%20approximately%205.3%20years.
But of course, HC Hickdead knows better.
Do I personally believe that this will happen here, instead of a P3 there'll be a post-marketing trial? No.
Did KK say that this is what will happen, no.
Yet this is what you keep implying as part of your "interesting" finding series.
I refer to the above image.
How about when you said there was no information anywhere about the first US site recruiting for our P2 trial in the US? Or that you must have a US office to run a FDA clinical trial?
I refer to the above image.
Since I havent had a chance to reference your precious yet, I will do so in the coming hours/days/weeks. TipRankGPT's cancer topic in relation to FBS, and interesting findings on how FBS can affect TNFalpha, a ghost from the past.Have I mention that Cynata's manufacturing process is not using FBS? They haven't misread claimed for years to work on not using it anymore, they have just gone ahead and developed a process that doesn't require FBS.
Your definition of "interesting" is misinformation, I'll intended, not because you are lazy or simple (not saying you aren't, just to be clear), but because it doesn't suit your agenda. You have made it clear that MSB is your favourite investment. Good one you, I hope you made good coin. But if you think that people don't see you for who you are and what you are trying to do over here in the disguise of discussing something "interesting" you found, oh dear. That might work with your little sidekick/s TipRankGPT. Your interest in discussing CYP is in the interest of mankind I suppose, but discussing your own stock, which you keep mentioning even on these threads, you expect us not to mention. Again, you can't tell me what I can or can't do. Deal with it or don't, I couldn't care less.
(20min delay)