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Thanks Hank,
When investing in any biotech, I always try to look at the worst case scenario, do my DD with a little gut feeling throw in. As I stated, even if the CD12 fails, there is still the HIV trial that has been completed and just needs the BLA filed and that is as close to a sure thing as any other biotech out there. I also thought about HGEN when the price was running parallel to CYDY post reverse split, but I kept getting a feeling of something not being right on that one, hope I am wrong, but I still get the feeling that things are not adding up. Their drug is a GM-CSF similar to the GSK drug that failed in trials and was only successful with patients over 70.
Material news according to SEC guidelines need to be disclosed within 4 days, does the clock start on the day of unblinding or thereafter I cannot attest too? This is material news that can cause the stock to go up or down by the way, does not necessarily have to be bad news. The question is does the confidentially agreement with another federal agency supersede the need to disclose. I do not know the answer to that question. At the end of the day for me, I got into this for COVID, but I stayed in it for HIV. As a biotech investor, I have never seen a company that had a back stop so to speak for another indication if one trial failed. We know the HIV trial was a success, and while the BLA fiasco has been a source of angst for the long term holders, it should serve as a level of comfort for any new investor. Yes it will be dead money for probably another year, but you only lose money when investing when you sell and I do not plan on selling if COVID fails. GLTA
I also believe that approval will be granted, as far as the primary end point being missed, I am not so sure about that. Many are speculating that the primary was missed, because TLD was not released. A couple of things give me pause about the primary being missed.
1. We know that the overall mortality was trending at around 23% in the trial, whereas in other trials the mortality in the placebo group was between 30%-33%. What could bring the overall mortality rate down in CYDY's trial when other trials were basically using SOC like our trial. The one plausible conclusion is that maybe the leronlimab arm had an inordinate low mortality rate. I think Dr. Yang's EIND had a mortality of 23% (I think i read that somewhere), keeping in mind that these were people that were at deaths door and probably had exhausted all other treatment options and probably received leronlimab late in the progression of the disease. This probably was not the case during the trial. The only reasonable deduction that makes sense with the overall mortality being low is the Leronlimab effect.
2.I have been investing in biotech for more then a few years, and have never recalled the FDA asking for raw data to be submitted. Is it possible that the results were to good to be true and the FDA asked CYDY to not disclose TLD, until they were able to crunch and validate the numbers, hence the two-three week timeline to report results? NP stated over a month ago that the FDA wanted the raw data, so the PR should not have been a surprise to anyone. He also stated that he would not release results until he had all the data, he learned his lesson from the piecemeal CD10 release.
3. Doesn't make sense to submit bad trial results to three different regulatory agencies. Keep in mind that the company is also trying to get HIV approval in these countries as well and it wouldn't look good to be trying to get approval on less then stellar results that could jeopardize any future filings for approval.
4. Lastly, if Friday after hours comes (72 hour adverse event expiration) and goes and there is not a PR indicating the primary endpoint was missed, I think that we all can be reasonably assured that the primary was not missed and there are other reasons behind the data not being released. If there is any inkling of Nasdaq uplist hold on to your boots, because that will be the clearest signal yet that the data is good.
All IMHO
Not only that, but if you look at the disclosure the warrants were set to expire in 5 days.
Loving the action here. My only regret is that I did not pick up more shares when I had the opportunity when it was in the teens.
Not at all. Although have not been in as long as some of the true longs on the board. I actually did disconnect, my time is better spent then listening to the resume of their new hire, not that it is important. As an investor, if I wanted to know about him, I would just goggle him and research for myself. My opinion was there was not a need for the call as based on everyone's comment and what I heard there was not any substantive information discussed. The company doesn't want to be known as the boy that cried wolf, as eventually people stop listening. Just my opinion.
I am long, but what a F''''ing waste of a conference call.
I don't think a P-value should be a major part of the calculation, if it shows a benefit to mortality it would be unethical not to approve for a EUA. Where was the P-value for Rem, with no benefit to mortality but a decrease in hospital stay. The same could be said for CV plasma, Regeneron and Eli Lily's emergency authorization request. The true measurement should be does it show a benefit and cause no harm, which is what Hahn stated when they are considering an EUA.
I agree with your assessment. There is more to this then just an announcement to continue the trial.
Here is how I am reading this press release, completely my opinion of course.
1. The call is to review the DSMC recommendation.
2. If the recommendation was to continue the trial, the company would not have access to the data, unless they were going to take the penalty.
3. Why come out with a PR on a Thursday, if the recommendation was to continue the trial. Just announce something after hours on a Friday evening. Why wait until a Tuesday to reveal this information and discuss regulatory path forward. Most investors would know if the trail was to be continued we would need to complete phase 3.
4. Perhaps the most telling and hopefully not a distraction a dog and pony show. There is a slide presentation. What is in the slides is the million dollar question. Maybe data, maybe a flow chart outlining regulatory path, who knows. I suspect that they have the data (IMO) and that is what may be in the slides. In any event, I think we will get a clearer picture on Monday during the trading day to see how it trades. The MM always know before the retail investor.
Just my 2 cents and analyzing what was said and unsaid in the PR.
Birddog
Definitely something is in the wind. Trading pattern at close was very erratic, so news will be out either later tonight or first thing tomorrow morning. Based on what I have seen previously from a trading pattern perspective something has leaked. Depending on what side of the fence you are on, shorts could have been trying to cover to get out before good news, or longs were trying to get out before bad news. Ladies and Gentleman place your bets.
Long and Strong and along for the ride either way.
Birddog
Prime reason why it was smart not to pair up with Rem. Safety concern could be completely related to Rem and not the antibody, but trial stopped none the less.
It will be a very interesting weekend.
I think that they will try all available treatment options, including Leronlimab if none of the other treatment options work. Boy would it be nice if top line data were to be released on Monday that shows reduced mortality in the leronlimab arm of the CD12 interim analysis. Timing is everything and sometimes it takes a little dumb luck for things to work out. Is this one of those instances, is anyone guess.
GLTA
I think that it is out of an abundance of caution because he is POTUS. What is really interesting is if he is having mild symptoms and they are treating him, this is being done to stop him from going to critical, yet the FDA did not see this as a priority from a EUA perspective with CYDY. Maybe this will put a bigger focus on mild/moderate treatment options. Interesting article just came out.
GO CYDY.
https://finance.yahoo.com/m/9adbd2f4-6def-3532-9336-506e71fcc765/trump%E2%80%99s-coronavirus-diagnosis.html
Interesting REGN up almost $20 afterhours on news.
Being treated with Regeneron cocktail. So much for Hydro, and Rem drugs that were touted. Will be interesting to see if it works.
CNN just announced that if POTUS requires treatment and the other drugs that have EUA are not able to treat that they would consider any experimental treatment not yet approved and that are in trials. Hope it doesn't come to that, but they are open to unapproved treatments because it is POTUS.
Laugh of the day!!
KCroyal Agreed,
Seems I remember you from another investment I was in, cannot remember if it was HGSI or CTSO. Were you in any of those?
GLTU
Ditto for me. I guess now we know why there is no longer a relationship with Dr. Patterson, all related to the receptor occupancy not being accepted by the FDA. Amazing how many were saying that Patterson needed to be part of the company and turns out that part of the reason of FDA delay is not accepting of his analysis.
One would figure that if there were that many deaths in the Leronlimab arm, the DSMB would have stopped the trial. While tragic, I think that this bodes well for the interim look, as the placebo arm counts double. The question is, does this warrant a recommendation to stop the trial due to number of deaths?
Rock,
That is the piece that doesn't make sense to me. If the companies trial protocol called for 350 mg and the results were stellar, as they were, why would the FDA just not approve the drug based off of the trial protocol for the dosage? Selfishly, I am glad that they did not as I would not have discovered the company if not for COVID. As a relatively new investor, I plan on staying regardless of the COVID results, as I believe the company has tremendous potential for many indications.
Is it possible that the FDA would approve mono therapy without a long drawn out trial? I think that was alluded to in a conference call at some point. If that is the case, is the delay worth the wait for approval, as this would open up additional revenue stream years earlier then what would have happened with having to do a trial. Just giving my thoughts, I could be way off base on my thought process, but that is how I am looking at it.
GLTA
I think that Nasdaq is still on the table. As I recall, when HGEN was going through the Nasdaq uplift there was chatter on that board about waiting for an S-3 to become effective in order to uplift. CYDY just filed an S-3 last week and this could be a prelude to getting on Nasdaq. I do not know if this is requirement, just that is what was being stated on the HGEN board,
GLTA
No kidding, they have to do a better job at screening the callers.
Looks like Chris Raknor has joined the company.
Raknor just said who the phase 3 study would work with. Meaning to me that a phase 3 is in the cards.
Couldn't agree more with your statement. You would have thought that they would have learned to play the game by now.
Let's see what the share price does tomorrow. My personal belief is that it may have traded sideways or went up a tick with it being a Friday and traders not wanting to potentially miss some type of catalyst announcement on Monday. That scenario is essentially taken out of the mix now. Is it possible that NP is springing a trap, making shorts believe that no announcement is imminent only to announce news on Monday. Possible, but highly unlikely as he does not seem that conniving to think this way. In any event, it is what it is at this point. Just along for the ride, like everyone else.
He could still do all those things behind the scene without telegraphing a conference call 6 days out. It just seems like it is amateur hour when announcing a call so far in advance, all it does is give the "naysayers" and shorts the opportunity to control the narrative and create their own spin on things. While it doesn't make a difference over the long haul, it is frustrating none the less.
Why do they feel the need to telegraph these conferences calls so far out. This is only playing into the shorts hand in knowing that no new information will be forthcoming until this date. They could have just as easily put out a press release on Monday after hours announcing the call. Share price will take a hit tomorrow since potential for surprise announcement is taken out of the mix.
What is going on with the US FDA trial in covid? They have announced many other trials in 3rd world countries, but nothing for the US. Since they filed several months ago, you would have thought that there would have been news by now.
Good luck with that. I sold and figured I wait until the dust settles. I do believe in the company.
If you have 10,000 shares now, once the split goes into effect you will have 1,000 shares. Technically the value stays the same as the price is 10 times what it may have been at the transaction date, however the price typically depreciates in the preceding days. This is not always the case, but in most circumstances this is what occurs. GLTA
One thing that perplexes me is why all the other Pharmas are being allowed to change the design of their trials and CYDY trial was giving the continuance without any changes. HGEN obviosuly increased their trial size, which sometimes can be the result of not seeing the efficacy that they were looking for. Also the change in RLFTF trail design will lead to them completing their primary endpoint 18 days sooner per patient as previously listed.
Go CYDY!!!! Another one bites the dust.
https://www.barrons.com/articles/nash-drug-trial-biotech-51595516379?siteid=yhoof2
Looks like it is getting ready to run. Volume has been picking up over the last week or so. Volume usually proceeds any uptick in price, there is definitively something in the air when average volume is usually around 145K and the last two days have almost hit 1 million shares. Let's hope the trend continues.
Birddog
Volume=price. Bring it on!!!
Great Post Georgie and I would second that!!