Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Cytodyn is listed on the 4 good website
And PIs sign protocols. What conspiracy theories do you make up about that?
And Paid sign protocols. What conspiracy theories do you make up about that?
The FDA regulations say the CRO is responsible. I've worked for several CROs and had that drilled into my head during training. If they just provide personnel and the company maintains the EDC, TMF, oversight etc., then it's a hybrid system and responsibility is in accordance with the MSA.
This was a big issue when CROs started so it was addressed directly.
No reason for a lawsuit is a good thing. A lawsuit would mean that Amarex misrepresented the work they did on HIV or Covid which would need to be repeated or remonitored for the filing. The arbitration is just about disputed charges.
No sites for GVHD. Sites are paid an upfront start up cost typically, paid for PI time, SC time, reg coordinator time, and tests performed. Larger institutions charge for med watch report review and standard overhead costs. If they use local IRB, those are pass through. Central IRB typically come directly to the CTM or project coordinator to approve. Those would be annual approval, med watch report review, document update reviews and close out. All sites typically get close out if they've actually been opened. If no sites were activated for GVHD, there wouldn't be site costs. Amarex was charging monthly. That's a CTM, project coordinator or a CRA putting in pass through. That happens if you don't keep a close eye on the costs. Everything indicates Cytodyn did.
They charged Cytodyn for work on the GVHD study even though Cytodyn had put that one on hold to save money. Amarex still had a charge back code for it and someone was using it. Cytodyn was paying other charges on time. Amarex used the timing for disputes charges item in the MSA to say that money was owed even though they should have removed those before sending the invoice through.
I think they had what they needed when they needed it and didn't want to tie up 6.5 million any sooner than necessary because they are fiscally responsible imo
They talked about that in December, I believe. That's when the FDA suggested they do a meta analysis of their data for the EUA. NP said in the proactive video that it would be part of their statistical analysis plan I believe.
I'm telling you guys - the job title they have posted is the exact title that Progenics used for Tracey's job and she was in charge of maintaining the TMF for the clinical trials. They wouldn't need someone for that unless they will have a TMF they are bringing back in house.
Senior document control specialist maintains the trial master file
Where do you see that correspondence? I just looked on Cytodyn's website and the only SEC letters they have filed there are from 2020. The SEC had questions about redacted info on their agreement with Vyera. Cytodyn sent them the requested info outside of Edgars and the SEC acknowledged receipt. That's all they have there.
Considering that Pharma Bro had his hand slapped for trying to stay in charge of the company while in jail and NP was let go not long after signing off on the change to the company they'd be dealing with, it's possible that the SEC, DOJ and NP termination all has to do with Pharma Bro and nothing else
You are arguing that it's saline solution. It's not. It has shown efficacy in several indication. Madrigal just PR'ed clinically relevant response in NASH. They never used the word statistically.
Leronlimab has shown efficacy in HIV, cancer and early signs in NASH. Saline solution doesn't do that.
And, the safety of the compound for s important. Madrigal also indicated in their PR that they needed so many patients on their study to show their drug is safe. Leronlimab has that in multiple indications in very sick populations. NASH studies are difficult to enroll. Having that safety data can only help.
Your arguments are not relevant to the multiple indications leronlimab has. Cancer and NASH especially would be most attractive to potential partners. The safety data should cut down on the time a partner would need to wait to find out how their investment pans out. It's a difficult indication and that is important.
It's from 2021
Nothing in there about study data. Just the regulatory file and an audit. Sponsor's normally help prepare a CRO for an FDA audit. Amarex can't keep the FDA away and if they don't let Cytodyn help them prepare, then Cytodyn's response to any findings is that they attempted to help prepare the CRO for an audit but were not allowed in.
Amarex has been charging regularly for the GvHD study which Cytodyn had put on the back burner and just updated to terminated due to nolack of enrollment on the clinical trials website. Amarex had no reason to charge against it for 2 years
Increase in volume lately. Increase in short volume. No huge drop in price even with what could be perceived as bad news. I think people who sold last year for tax losses are getting to the end of their wash periods and are quietly buying up the shares the shorts are using to keep the price below $1 so we can't get uplisted to Nasdaq using alternative rules now that we have revenue.
I saw a post on Yahoo that we got the database from Amarex right away and the bond is only needed for the TMF and access to the site for an audit. The on site audit would be for the TMF. That's normally audited in preparation for an FDA audit for drug approval. It still needs to be maintained by Amarex because they'd have to allow FDA to audit it and would get hit with findings if it's not maintained properly. The TMF is basically the study documents, copies of documents maintained at each site (investigator site file) and the CRA trip reports and confirmation and follow up letters. The CRO is responsible for those.
As long as Cytodyn has access to the data, the rest can actually wait unless they need CRA documents to show that the CRO didn't follow their SOPs. The ISF can give you an idea about that based on confirmation and follow up letters.
As long as Cytodyn has people who understand clinical operations and they have their data, they could wait to find out how much they actually owe.
By Monday, everyone who sold for a tax loss on anything in 2021 can buy back in. It was a crazy year.
One more day until you can buy back in at half the price if you are so inclined. The shares short went up by 9 million mid month. It was at 40 million on January 15th. Most I've seen.
Today is the end of the wash for anyone who sold by December 28th.
The SEC today approved required periodic reporting by hedge funds of short sales
Terminating his employment was the nicest thing they could do for NP in the situation. He did so much for the company and if he'd quit so they could get someone with pharma experience as CEO, he would have been left with nothing. Especially since he sold a bunch of his shares to purchase warrants and help them through a rough patch. Quitting would have meant no golden parachute. They thanked him for his service in the PR which, to me, means they did end on good terms.
The SEC doesn't have to require a quiet period for a company controlling the purse strings to want certain info to get out in certain ways and on their time table.
Not saying that I think they have a partner, but earning season is now for some pharma's - J and J out today. You can't assume it would only be Cytodyn's need for a quiet period before earnings.
They're biologics. There is no formula the way there would be for a small molecule. You'd have a salt form of a small molecule to bring it in and out of solution more easily so you could purify it. Salt in a biologic would be part of a buffer to keep it suspended and from degraded to quickly. It wouldn't have a salt added to it the way a chemist would do for a small molecule.
The mRNA vaccines don't have antigen exposure the way a classic vaccine does. They use the body the same way a virus does to create the antigen within the body so antibodies can be raised.
I believe attenuated viruses are less common for classic vaccine and instead the antigen is genetically inserted into a vector/plasmid, copies are churned out in large flasks and the antigen bearing vector is purified and added to a buffer solution (which would include salts) and put in vials for distribution.
The salt you put on your salad is NaCl. Na is positively charged. Cl is negatively charged. The easily pair up and separate in solution. Anything with a Cl on it that can do that is a salt. Anything in the same column as Na can do that because of the number of free electrons and the ease and stability of pairing. The reaction gets more volatile as you go down the list. Those are your big boom molecules when exposed to water quickly and in large quantity.
Biotech Showcase finished up this week. They had over 2000 attendees, 80 presenters and 54,000 requests for potential partnership meetings through their system. Cytodyn was one of the presenters
Look under the scientific advisory board tab. He's at the bottom.
He's on the scientific advisory board. CV and credentials are necessary for that.
I don't think the delay of the conference call is anything more than them presenting at Biotech Showcase this week and wanting the data fresh for the presentation.
It's in vitro because they're using blood samples from their repositories. It's a typical request from large institutions to ask patients in studies to donate blood samples at baseline and possibly completion so that investigators can use them for basic research to answer questions and to publish. In vitro just means in a tube. Any blood test is in vitro.
They self reported. Clinical trial SAEs would be reported to the FDA by the company on a Medwatch report and linked to the IND. Most would be expected to be reported within 15 days. Deaths within 5 days. They are typically reported irrespective of causality. SUSARs would be followed more closely, typically would require an update to the IND and confirmation that the investigators and their staff are aware of the unexpected and related SAE.
Those are the adverse event tables. The fact that they are no different than placebo is good. It means they have no more side effects than taking placebo. That is different from symptom relief. Symptoms would be captured at baseline. Adverse events are new complaints that arise during the study. A resolution of baseline symptoms would not be seen as a signal on an AE chart or table.