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Um, hankey, youre no good at this msg board argument stuff and proven to lie about it so stick with the fictional cartoon character thingy youre so obsessed with and emulate on a grown adult stock message board.
Fess up, did I or did I not ask you for the MSA signature page?
I already proved it, so go thru your little southpark cartoon tv character preamble and admit I asked you for the signature page.
Um, hankey, you gonna post that Amarex MSA signature page or not?
You posted "page 2 of 18"...post "page 18" (or whichever the signature page is) and move along.
Stop wasting everyones time with bullshit that doesnt answer a direct question.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173185896
Geez just admit you posted the UNSIGNED document that was ADMITTED INTO COURT AS EVIDENCE and leave it at that.
You DO know it can be proven you posted it right?
RIGHT?
Tractors? Construction loans? Dont go clueless loser on us now hankey.
and what's my heritage? = C J
And just admit youre to dumb to find the link.
No need for me to go back and forth with you since its confirmed you cant contribute any DD.
Nah, CJ describes you perfectly. Own it.
You dumbass...cant find a "procedural" hold link...youre a disgrace to your heritage.
Um, mr cj sir, did you ever find that "procedural" FDA FULL HOLD link I asked you approx 4 times already?
Ahhh, so CYDY mgt refused to say which of these reasons the FULL HOLD was imposed right?---
(i) Human subjects are or would be exposed to an unreasonable and significant risk of illness or injury;
(ii) 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;
(iii) The investigator brochure is misleading, erroneous, or materially incomplete; or
(iv) The IND does not contain sufficient information required under § 312.23 to assess the risks to subjects of the proposed studies.
(v) The IND 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 or potential risk from use of the investigational drug of reproductive toxicity (i.e. , affecting reproductive organs) or developmental toxicity (i.e. , affecting potential offspring). The phrase "women with reproductive potential" does not include pregnant women. For purposes of this paragraph, "life-threatening illnesses or diseases" are defined as "diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
(i) Any of the conditions in paragraphs (b)(1)(i) through (b)(1)(v) of this section apply; or
(ii) The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives.
(3) Clinical hold of an expanded access IND or expanded access protocol. FDA may place an expanded access IND or expanded access protocol on clinical hold under the following conditions:
(i) Final use. FDA may place a proposed expanded access IND or treatment use protocol on clinical hold if it is determined that:
(A) The pertinent criteria in subpart I of this part for permitting the expanded access use to begin are not satisfied; or
(B) The expanded access IND or expanded access protocol does not comply with the requirements for expanded access submissions in subpart I of this part.
(ii) Ongoing use. FDA may place an ongoing expanded access IND or expanded access protocol on clinical hold if it is determined that the pertinent criteria in subpart I of this part for permitting the expanded access are no longer satisfied.
(4) Clinical hold of any study that is not designed to be adequate and well-controlled. FDA may place a proposed or ongoing investigation that is not designed to be adequate and well-controlled on clinical hold if it finds that:
(i) Any of the conditions in paragraph (b)(1) or (b)(2) of this section apply; or
(ii) There is reasonable evidence the investigation that is not designed to be adequate and well-controlled is impeding enrollment in, or otherwise interfering with the conduct or completion of, a study that is designed to be an adequate and well-controlled investigation of the same or another investigational drug; or
(iii) Insufficient quantities of the investigational drug exist to adequately conduct both the investigation that is not designed to be adequate and well-controlled and the investigations that are designed to be adequate and well-controlled; or
(iv) The drug has been studied in one or more adequate and well-controlled investigations that strongly suggest lack of effectiveness; or
(v) Another drug under investigation or approved for the same indication and available to the same patient population has demonstrated a better potential benefit/risk balance; or
(vi) The drug has received marketing approval for the same indication in the same patient population; or
(vii) The sponsor of the study that is designed to be an adequate and well-controlled investigation is not actively pursuing marketing approval of the investigational drug with due diligence; or
(viii) The Commissioner determines that it would not be in the public interest for the study to be conducted or continued. FDA ordinarily intends that clinical holds under paragraphs (b)(4)(ii), (b)(4)(iii) and (b)(4)(v) of this section would only apply to additional enrollment in nonconcurrently controlled trials rather than eliminating continued access to individuals already receiving the investigational drug.
(5) Clinical hold of any investigation involving an exception from informed consent under § 50.24 of this chapter. FDA may place a proposed or ongoing investigation involving an exception from informed consent under § 50.24 of this chapter on clinical hold if it is determined that:
(i) Any of the conditions in paragraphs (b)(1) or (b)(2) of this section apply; or
(ii) The pertinent criteria in § 50.24 of this chapter for such an investigation to begin or continue are not submitted or not satisfied.
(6) Clinical hold of any investigation involving an exception from informed consent under § 50.23(d) of this chapter. FDA may place a proposed or ongoing investigation involving an exception from informed consent under § 50.23(d) of this chapter on clinical hold if it is determined that:
(i) Any of the conditions in paragraphs (b)(1) or (b)(2) of this section apply; or
(ii) A determination by the President to waive the prior consent requirement for the administration of an investigational new drug has not been made.
(c) Discussion of deficiency. Whenever FDA concludes that a deficiency exists in a clinical investigation that may be grounds for the imposition of clinical hold FDA will, unless patients are exposed to immediate and serious risk, attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order.
(d) Imposition of clinical hold. The clinical hold order may be made by telephone or other means of rapid communication or in writing. The clinical hold order will identify the studies under the IND to which the hold applies, and will briefly explain the basis for the action. The clinical hold order will be made by or on behalf of the Division Director with responsibility for review of the IND. As soon as possible, and no more than 30 days after imposition of the clinical hold, the Division Director will provide the sponsor a written explanation of the basis for the hold.
What the hell or who the hell is CJ? Ever seen the Dubai camel races on TV?
Youd rather throw a tantrum/hissy fit than post a link to "procedural" hold eh cj?
I would say going immediately from a partial hold to a full hold qualifies as being "frequent".
Whats the matter cj...too ignorant to post a link to "procedural" hold?
Buy a stock and profit from it for once in your life CJ.
All you ever do is bitch and whine.
Wheres the link to a "procedural" hold?
EXACTLY! Then theres the partial hold removed then new full hold added is like driving by a gas station displaying $4/gal then driving by the same station 5 hours later now displaying$4.25/gal.
Same gas, same gas station except the employee "removed" the $4 price in order to display a worse price of $4.25.
Didnt I ask you to google "FDA procedural full hold on a proposed clinical trial" and post the link please.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173438026
And as you can clearly see, nobody has stopped DD-ing this stock because your little insecure fear infested brain doesnt like what being posted.
Naw, they dont want to talk about a full clinical hold, and yes thats NOT normal.
Then, to top it all off, WITHDREW the BLA--- today announced that it has voluntarily withdrawn its pending Biologics License Application (BLA) for leronlimab
https://finance.yahoo.com/news/cytodyn-announces-voluntary-withdrawal-bla-211500961.html
How many "just wait and see" moments will this make...50? 200?
Google "FDA procedural full hold on a proposed clinical trial" and post the link please.
You basically said the same at the 41 cent top.
Need me to tell you what happened next?
You crack me up my little (ahem) CJ friend.
Why do you sound so disappointed?
A proceeeeeeedural full hold on a PROPOSED clinical trial.
Think about that one for a minute folks.
Did yall happen to notice Lalli is the 3rd Iranian at the helm of CYDY?
Pumpty dumpty sat on a wall, pumpty dumpty had a big fall.
All the kings horses and all the kings men couldnt put pumpty back together again.
Um, bagholders, how can a PROPOSED (a clinical trial that doesnt even exist yet) clinical trial be placed on a FULL HOLD?
Also, google "FDA procedural full hold" and get back with me. Far as I can tell its not even a real thing.
newly proposed clinical trial protocol which resulted in the procedural “full hold” that is currently in place. The Company believes the “full hold” will be removed after we adequately respond to the FDA’s comments and incorporate the FDA’s specific guidance as it relates to the proposed protocol.
https://www.sec.gov/Archives/edgar/data/1175680/000110465923126211/tm2332979d1_424b3.htm
Um, losers, dipped into 24s territory.
Yep, first of all NO 8K FILING AT THE BEGINNING OF DECEMBER 2023
Hmmmmmm, strange to say the least.
Secondly, is it just me or does mgt sound a little pumperish in trying to spin the ((((((((FULL HOLD)))))))) situation?
Now in da 25s???? LAUGHING
That’s you bro. PROVE IT
The same thing can happen to I_luv_cydy on X too.
You idiots have to be the dumbest bunch of grown adult losers that will believe just about anything.
Im flattered to see some clown go through the time and effort to create an account on X and use my moniker and avatar tho...
It tanking again losers. Leronsaline is worthless. Its been tried and tested over and over and over again.
Oooooooh Im scared shitless. Lets see if that stops me from posting DD on this message board.
Looks to me like the partial hold on HIV has been converted to a ((((((((FULL HOLD))))))))
WEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE!!!!!!!
Um, dumdum, you gonna comment on the FULL HOLD or not???
Is that a "no comment" on da FULL HOLD in effect?
When will you get it thru your little thick skull that the market reacts to FULL HOLD and NOT STATISTICALLY SIGNIFICANT stuff instead of what your small mind perceives to be important on message boards?
"FULL HOLD" via 8K filing and you focus on some clown with nonsense?
Why wait until tomorrow, do it now.
CYDY closed red in da 19s...fact.
Somebody lying? Wheres the 8k within the 4 business day time frame for this statement?
The Company received a letter from the FDA at the beginning of December 2023 notifying the Company that: (i) the “partial hold” implemented by the FDA in March 2022 had been lifted;
https://www.sec.gov/ix?doc=/Archives/edgar/data/1175680/000155837023019804/cydy-20231214x8k.htm
New "FULL HOLD"!!!!! FDA basically says these idiots stay right where theyre at and dont move a muscle.
BWWWWAAAAAAAAAAAAAAAAAAAHAHAHAHAHAHA
Hold still ongoing? Anything new other than---
You must be mad
Bashers going to jail, just wait and see
Fuzzy fizzy fooey fda phizer
Wheres the bankruptcy? No bankruptcy?
Dont get me started on Gary the two bit message board psychologist that secretly hates the co and himself for being stupid enough to get duped.
And yet these bagholding losers blame message board yip yap to be the culprit for the stock trading at 20 cents.