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Thanks. It’s good to have your perspective. And very good to have strong results!
Misiu - were do you see that all patients with CYDY improved? I only see statements that results were statistically significant and that all patients go on pro140 for 24 weeks. Just want to make sure I’m not missing something....
But still high compared to last two months...
Spoke with Redman last week. I plan to type up my notes and can post them here if people think is helpful. He was very responsive and engaged, but no earth shattering updates. Here are the highlights if you are interested. Hoping for a good PR soon on enrollment and dosing.
1. Drug arrived safely on location on 1/10
2. Once drug was received and verified, ONCX instructed principal investigator to begin enrolling. This is typical protocol for companies to wait until drug is onsite and verified before enrolling.
3. He had not - at the time of our conversation - spoken with the hospital. So he did not know if anyone had been enrolled or dosed yet.
4. His said he planned to call the next week for an update.
5. Once a patient is enrolled they will begin dosing the next day.
6. Still actively searching to acquire new molecule to diversify pipeline.
7. Considering adding another board seat and establishing an advisory committee.
8. New research opportunity w MD Anderson has begun for uterine tumors, but very early. No real update yet other than “so far so good”. He was not able to expand on that at the time.
9. 10k coming in March
Ok. Just took a closer look. You are right. I saw the transaction type A and assumed they were being executed. But I was wrong they are just being issued. Sorry for the mistake. Thanks for correcting.
Moderators - please delete my post to avoid confusion.
I also agree with BD. But I think it is more than likely they will over enroll considering they have in the past and it really is the prudent thing to do w such a small sample size. With that said, timelines are impossible to predict bc we don’t know how many they wish to enroll, how many are already enrolled, or the rate of enrollment. Management says PE by end of 1Q. So that’s the next milestone. However I wouldn’t get my hopes up too much given past deadlines.
I don’t believe they need FDA permission to unblind but will likely seek it anyways for the reasons BD mentioned.
It’s not a straight forward raise. It’s the convertible notes maturing. The company is repaying those notes (well all but $300k) with shares. The notes had warrants with them. It appears the company has double the amount of warrants associated with them (I may not be reading that right though).
The shares and warrants are immediately separable so we may see SP range down some as people liquidate shares and hold warrants. If you were already incorporating these convertible notes as outstanding shares than the only dilutive affect would be the extra 3.9mm warrants issued. Again. I think I’m reading that right.
I totally agree. Cydy is a winner and we are all anxious to get a lot richer.
You also said combo enrollment was complete. And have yet to tell me how that was misinterpreted...
I guess the lesson to be learned here is to be more intentional with sharing facts.
Frankly, after reading your random and inflammatory posts for the last year in which your position on this company fluctuates from severe bear to severe bull, I assumed you fabricated the entire call. I no longer think that and could have given you additional time to respond.
I do call and email for myself. That’s why I’m suspicious when i see others claiming to receive alternative facts than me.
Yes it was your mistake. I’m glad you are owning. But I’m heavily invested here as well. And facts matter to me. I posted earlier this morning asking you and saltz to clarify these comments before I took my questions to Jody. Neither of you chose to respond even though pearsby you have been active on the board. So I took my questions to management. If management becomes less transparent than they already are (which may be impossible) than that’s on your hands. Not mine.
Pearsby - thank you for clarifying. Mistakes happen but I’m still wondering what was exactly said about enrollment. Your prior post says “Good news, Combo is fully enrolled and additional patients will be continually enrolled in Q1 and Q2. The "N" could be 55, 60 or more... possibly prior to BLA submission.”
What was exactly said here? Did he specifically say they had the 50 and were continuing to enroll?
Also, how can they continue to enroll up to BLA submission? If they are still enrolling than the trial is still open (I.e. data is still blind) and I assume they can’t submit BLA prior to closing and analyzing Data...
Axe99 are you a moderator? Just trying to understand your responses and how you could think those claims are “reasonable and essentially accurate” even though the company formally denied them.
I can share the email if need be from Jody.
I just confirmed with the company that they are not...
Jody’s Response
I asked Jody about several claims on this board about the poster claiming direct communication with Tony and that Tony said enrollment was complete and a Pre BLA meeting had been scheduled.
After receiving my email she directly contacted Tony. Tony claimed to have only spoken with one investor recently and DID NOT give any indication about enrollment and/or a pre BLA meeting.
It’s frustrating for so much misinformation to be spewed on this board for no reason. I’m directly this at both pearsby and saltz. There’s enough to be positive about with CYDY. We don’t need that noise.
Just heard from Jody
Nothing really new she could share outside of what was printed on the deck. Which really leads me to question many of the posts recently claiming full enrollment has been achieved and a pre BLA meeting has been scheduled. I responded to her email asking about those claims that apparently came directly from Tony. I have not heard back on that front.
I would caution the board in believing such claims. If the are true than they are likely illegal.
Saltz and pearsby.
Did I miss something about a pre BLA meeting with the FDA being scheduled in March/April (re: pearsby post)? Or are you both just assuming that timeframe?
I 100% agree grip. The idea that management to too busy to provide updates is insane. They are a public company! This is Jody’s entire job.
Grip have you contacted Jody about this?
I totally agree. Management’s communication has been atrociously bad. I emailed Jody again this morning with that sentiment.
I encourage everyone invested in this company to contact Jody with the same message. We all have a right to hold management accountable but if you are just posting frustrations here and not voicing them to the company nothing will change and we will all just continue to be in the dark. The company is busy but they aren’t administering the trials. They have the time and the fiduciary duty to communicate with investors. Here is Jody’s email. I hope everyone contacts her.
JCain@lhai.com
Thanks for recirculating that post. I had not seen it before.
Yesterday, I communicated with Redman through email followed with a more detailed phone conversation. Here is a summary of those communications as accurately as I can restate them.
- Clarified recent quote in Global News article that dosing for Group 2 would start in the very near future, and he expects ALL patients from Groups 2 and 3 to complete dosing before YE.
- The trial protocol requires at least 12 patients and a max of 18. Redman currently expects the company will only need 12 patients – Group 1 = 3 patients; Group 2 = 3 patients; Group 3 = 6 patients. However, more than 12 could be enrolled for various reasons (i.e. death, dosing complications, etc.).
- Up to this point, trial administrators have communicated to Redman that the only side effects noted have been itchiness and redness at injection site. At this point there have been no dose limiting or significant adverse events related to the drug noted. He stated how rare this is for SOC cancer treatments.
- Once the third patient in the mid-dose group completes initial 28 days of treatment AND a 14 day safety stop, the company can commence dosing in the high-dose group.
- Rate of enrollment is obviously not an exact science, but Redman seemed very confident that Group 2 would fully enroll and began dosing in the very near future. His wording was something like… We are obviously not dosing anyone today because the drug is being shipped from manufacturer, but I expect dosing to begin very quickly. He seemed very confident that the trial should go smoothly and relatively quickly.
- He clarified statements in prior investor decks on observed evidence of efficacy. Obviously, this trial is not structured to evaluate efficacy, but there are certain tests being conducted that can imply signs of efficacy. Many of these test results will not be evaluated until the end of the trial. However, the company has been able to compare biopsy results from low-dose group at Day 0 and Day 28. He did NOT indicate that the company would release or comment in detail on these results while the trial is ongoing. While he could not go into details of these results he said the bio marker results have been analyzed and provided some evidence of efficacy. I want to be careful here and make sure everyone understands that evidence of efficacy does not equal efficacy, but it was positive to hear.
- Redman was disappointed that the recent news of moving forward with the mid-dose group was not more positively received by the market. I explained that the quote in Global News appeared to imply that the mid-dose group would finish dosing by YE rather than both mid and high-dosing groups. Additionally, many investors (myself included) were unclear on when recruitment and dosing of the high-group could begin. As a result, many of us translated this into a much longer time horizon than we were expecting. However, I feel Redman addressed both of these areas satisfactorily. After my discussion, I am now of the opinion that dosing will definitely be completed by YE if not much earlier – IMO.
- Finally, Redman obviously checks in on this board occasionally to gauge investor sentiment. He seemed to be frustrated with the amount of nonsense and flat out fiction is being propagated by many on the board. He acknowledged that goes for both some bulls and bears. I let him know that most of us on the board can largely separate the chaff from the wheat, but it is often hard to stomach at times. He appeared offended by some of the more outlandish and untrue statements made about the character of his staff.
Overall, I left the conversation with more confidence in both management and the trial. Redman was very approachable and said that he tries to respond to all serious investors who reach out. I remain bullish on this company but definitely see it as a longer term play (>12 months). I and some other colleagues have built a small-medium size position. I plan to slowly build that position over the course of 2018 (hopefully with earnings from other investments on a shorter timeline to profits). Please let me know if anyone has any questions.
I spoke with redman yesterday. He was at the conference. Had a very helpful conversation. I will summarize later this morning.
Depends of your own personal investment timeline. I picked up a couple thousand more this morning at .56.
I disagree on all accounts here Fred with exception to your criticisms of managements communication. But everyone knows how I feel about that.
First convertible debt - a company issues such vehicles with the intent to eventually convert to equity while providing borrowers cash flow intil it’s advantageous to convert. It’s standard practice. It’s not meant to be a back door. That doesn’t even makes sense.
The recent delays are discouraging but not totally the firms fault. The only thing they control is communication at this point, which is horrible. I think it’s a big mistake to assume these delays point toward disappointing PE. Fact is ... data is blind, which means management has no real idea what PE will look like. Remember the trial is being administered by a third party. The ONLY piece of information we have about PE is that the IDMC recommended the trial continue. That’s positive if anything.
Lastly, applying a financial metric like the current ratio to a pre-revenue biotech company deep in pivotal P3 trial is ridiculous. You can’t apply your finance 101 analysis to this company.
Lastly, you keep talking about time to revenue...and we all keep telling you no one cares. This company will NEVER have revenue. The end game is buyout.
We get it Fred. There is still risk in this trade. More than I thought there would be at this point in time. But the potential reward is massive. Everyone here who is long is willing to accept that risk. But please get your facts together.
The 10Q was not comforting for several reasons. But none of those reasons changes the fact that it’s all about PE. I have no idea when that data will come and am furious that management doesn’t provide some guidance on that. But if your argument is that we should sell our long held positions this close to the finish line you are insane.
We all do. For at least two reason. 1. Money 2. To never hear from pearsby again.
Misiu - haha well I hope it doesn’t matter in a few weeks either. I’m hoping for Monday!
Misiu - fair enough but providing updates to missed timelines shouldn’t be a big lift for a management team of a publicly traded company. I continue to encourage frustrated investors to appeal to management for better communication understanding that they can’t make enrollment happen any faster.
Misiu - we are obviously in the same place. I always appreciate your posts and insight with your medical background. I hope you communicate these thoughts to Jody as well. When I talked to her she seemed unaware that many investors while very bullish and excited about the company are also frustrated with the level and quality of communication.
A fair assessment Fred. Our risk appetites are very different and I don’t believe the company is bankrupt on bad combo results but I understand and can appreciate your perspective.
I think there will likely be more time for you to get in if results are good so it’s a reasonable plan. Although, with goods results I’m sure the buy in price will be much higher as no one will want to sell. I’ve reached my risk threshold with the company for right now as well but am prepared to double down if results come out, if possible. If that happens then this trade is all but derisked in my mind.
Fred. I hope you are right but a simple PR to update timelines and enrollments at this juncture would be easy and cheap. Also, help investor moral. They still need us to get across this finish line, especially if they are crawling.
On another note, I’m curious since you mentioned you hope the company is crawling across finish line. Does that mean you no longer think a massive dilution is coming? If so, have you taken a position yet? Just curious.
Thanks Michel. I’m glad other shareholders are holding management more accountable for better communication. I hope others on this board will follow suit.
Fact is we don’t know if they have 50 now or not. Speculation on timelines is really just throwing darts.
I think a better use of all our time is to contact Jody and let her know many of us want better communication and timeline updates. That’s really all we can do.
I think using the enrollment rate of the trial prior to meeting with FDA is overly conservative given the requirements were eased significantly. But I certainly won’t fault you for being conservative on time lines with this company’s track record.
I will simply say that all news given to this point by the company has been positive in regards to final valuation. While I wish things were progressing there has been no information provided that lends itself for us to doubt that we will all be very happy with the end result even if it takes a while. However, I repeatedly communicated to Jody that investors expect better communication from management and that if timelines are significantly missed they provide updated timelines. Who’s to say if they listen to me at all.
Bucky. Let me add this...the deck that the company intended to present at the LD conference in December that was cancelled still said that final PE results were expected in 4Q17. IMO that means that enrollment was either full or damn close at that point.
My bet is all 50 have been enrolled and at least through PE. What I can’t speculate on is whether the data is still blinded to the company or not. So I can’t make any estimates on when we may see that data either.
Bucky. Those were my questions almost verbatim. In short to your first question, management never planned to unblind interim data or release to us, which is what I and others expected from listening to the call. If you listen again to the call, Nadar’s opening remarks clearly say that the review of interim data would be conducted by the IDMC and not management (5;35). He never said the data would be unblinded to CYDY or released to the public. However, Tony used different and less clear language later in the call (11:50) just before the QA section that I feel was slightly misleading and led me to believe we would see data in the 4-6 week time period. Jody was very adamant that was not what management intended. I asked her to share with management the confusion that statement caused to many investors.
As for your second question, let me clarify what I mean by close. I meant that I believe this trial is probably fully enrolled at this time. With the relaxed protocol for combo enrollment I would be shocked if it was not. However, I am not saying that I necessarily expect data to be released soon. Management has not provided any indication on when they plan to release PE. If you listen carefully to the call management says they expect final PE to be achieved around 8 weeks but they did not say when the data would be unblinded to the company or released to the public. They could release data a couple weeks after PE is achieved on all 50 or they could wait until the end of the full trial (I hope not but what I’m trying to say is that’s up to them).
Regardless, I let Jody know that we would appreciate more clarity and specificity from management on timelines and expectations.
bored lawyer and the rest of the board. I spoke with Jodi last night and it helped clear up the timelines for me a bit. I was very straight forward that many investors interpreted management's remarks on the Oct. 19 to mean that the FDA had given the company permission to unblind and analysis the data from the first 40 patients while enrolling the last 10 AND that we interpreted the 4-6 week time frame to mean that that data would be publicly released in the timeframe. However, she explained that was not correct. She reread the transcript from the call where management did mention the review would be conducted by the IDCM in the 4-6 week period. I relistened to the call and have to admit she was right and I must have just heard what I wanted to hear. We received the IDCM PR a week after that timeline but I no longer consider it a missed timeline. I can't believe I missed that, although I let her that the management's communication on what investors could expect and when needs to be clearer.
I then asked about the timeframe given for final results. Her response was that management doesn't have direct control over enrollment and was just providing an estimate. I asked many many other questions about the various other trials and any timelines for future updates, most of which she would not answer given that she could only discuss what was in the public domain.
While I still think management needs to improve the communication especially regarding timelines and expectations, I am now more frustrated that I didn't catch the language in the first place. This trade is so close to finish line and I am very bullish. Let me know if anyone has any questions.
Why don’t you enlighten us biotech??
Just curious why the October deck still used the TVEMF terminology for the heart study.