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Wow. Things good get exciting soon
You make reasonable points. I have not been in the prerevenue biotech market for long. But I imagine most pre-revenue companies with only one drug look like CYDY. How could they be flushed with cash? Their only way to get cash is dilution....
What poor financing decisions are you referring to? I've only been following the company since last November.
The bored lawyer speaks truth. Volume is the thing to watch. For this company at this stage everyone is pretty much where they want to be. SP movement from nominal trading volume is not a good measure.
Anyone thought about potential impacts on CYDY if are president shuts down the government when he doesn't get his wall? (He said he would this week).
True but I doubt the enrollment for GvHD is anywhere near as intensive as the combo. The requirements are not nearly as restrictive. they obviously have put some resources into it since they dosed first patient months ago.
Always so quick with factual data BD. Thanks!
I love it
Looks like we could also have a PR on full enrollment for GvHD soon with PE data available in 1Q18. But trial is double blind like combo.
That could be big boost to valuation if we get Positive PE back before BO! I for one hope we do not sell in 2017. If PE for combo is good then why not wait another quarter or two to sell. Trends are looking to good. I'll take the dilution if need be and then leverage up and double down after. If PE for combo is good this stock is derisked in my mind.
Ok. Change of subject here. I was trying to remember the details of the P2 GvHD trial. I know in the June presentation they had treated 1st patient and enrollment was ongoing. Does anyone know the protocol, sample size, and timeline for that study?
Would love to know if any of that data is open to potential buyers as well.
Good question. My guess is that the real event is PE from combo. That first week data will determine the big move but it's also tricky given the protocol. With only 30 very sick people and a short efficacy window, any statistical anomaly could make results inconclusive. That coupled with the financing situation would undoubtedly lead to big dilution at small SP. the timing of this trade is just as crucial as the drug.
Agreed. The company has identified competition. I highly doubt the work them into daily conversation... we beat the ibzjdjk drug to death. Let's move on
As long as they pay at least $10 a share, I'm ok with almost anyone buying it. Except The Donald, he has to pay at least $20 a share.
Ok. This whole conversation about pro140 and izbdjdjx is a waste of time. Everyday we all acknowledge that pro140 value comes from mono... izvdjnx doesn't impact that market. So for the love of all that is holy, Fred, stop bringing up a drug that doesn't impact the real value of CYDY. Please I just wasted ten minutes reading nonsense. Of course IMO
Misiu and blackdoggie are correct in my understanding as well. No possible way 25 patients have completed 25 weeks. I went back and read PR and not sure how you are getting to your conclusion.
As mentioned, only 12 were enrolled in at the Jan/Feb timeframe. So the PR could mean 11 out of those 12 have completed the 25 weeks. The 12th could have another couple weeks depending on when exactly they began treatment. To be enrolled does not always mean that treatment has begun.
Thanks Salt. I'm assuming the data is definitely still blinded since the 34th patient was likely enrolled this week.
Clarifying question: the PR seems positive with all facts, why did you mention you would have a hard time staying in without tony at this point? Is there something worrying you in this Pr that I don't see?
Fred! They just enrolled the 34th patient this week. The data is still blind, man. They can't analyze and report data until they finish the 1 week phase and the FDA unblinds the data.
PR seems all positive to me. I'm guessing the PE data is still blinded though which is why they only gave results on the 25 week open label part. Can someone confirm?
If that is the case then what exactly are the bears seeing as negative?
Another question, I'm assuming the PE data is still blinded. Does that data stay blinded until the Oct 17 meeting or does the FDA unblind it prior time to the meeting so the company can analyze prior to the meeting?
Well said JPG. Current SP only matters for raising capital not in a BO negotiation. You are also right about the open label of mono.
However, an additional consideration to an earlier BO is competition. Their are several big players in the HIV world that desperately need to maintain market share (especially Gilead). If efficacy for combo is good and safety data for both P3 is good. Then there is real pressure for potential suitors to begin negotiations. That's best case bc CYDY has leverage. Aka bidding war
Final thought. As we have said many times the BO valuation is based mostly on the mono potential (since combo is not a game changer and other indications are so early on). I don't remember the number but there are quite a few patients that have already been on Pro140 only for extended periods of time with great effectiveness. Most well known example is Charlie Sheen, who has been on the drug as mono therapy for about two years with suppressed viral load and zero SAs. The drug definitely works for some people, which means there is value in the company even if the strict protocol of the combo trial are not statistically significant. The mono trial will give us more clarity in the breadth of that effectiveness but we already know it works very well for some.
Well said saltz
I appreciate the other perspective. I'm all bull here but like hearing the Bear arguments. Fred, I say keep it coming. If nothing else the back and forth makes me more confident in my decision to hold on.
Fred - I understand your concern and if I dwell on it too much I get anxious as well. But I think there are logical reasons for both positive and negative conclusions. You pointed out some negatives. But as has already been pointed out the FDA is the one who unblinds the data not the company, if I understand the process correctly (and it is certainly possible that I don't). If i am right then it's certainly plausible for the wait being due to a million different reasons that always makes the FDA late. The reality is there's not enough facts for us to really reason anything more than just speculation. If it's keeping you up at night... sell. If you want to see the river card... stay in. That's at least what I keep telling myself. The only real facts we have gained in the past month is that combo has enrolled 33 (and counting), a meeting with the FDA has been set up, the company will need cash in the near future and mono has enrolled over 100. Those facts alone tell me we are closer to seeing the finish line but shouldn't necessarily make me any more incline to knowing what will actually happen. It's a waiting game... that's what I've learned. To quote The Bondock Saints when asked how far they are willing to go. "The question is not how far. The question is do you possess the constitution, the depth of faith, to go as far as needed."
Not sure the quote fully applies but it's and awesome quote and I never get to use it. Haha good luck to us all.
Fear*
Or the sale the sale has nothing to do w the rumor. If it does then it's just free. As we have said and keep saying the PE data is all that matters right now and it is locked down.
Thanks for keeping us posted.
Any indication of the terms of the potential raise?
No way this was insiders. To close to big event. That's a one way ticket to the big barred house.
I was able to get a chunk as well only about 5,500 filled though
I should clarify. If combo results are not great, I assume it's more due to the structure of the trial than a failure of the drug.
Not exactly true Fred. In contrast to the blind combo trial, the mono is open labeled as blackdoggie has reported on many times. It also has over 100 people enrolled. So when combo results come out, a potential big pharma company buyer can sign an NDA and have access to the ongoing results of mono. I'm thinking mono enrollment will close by year end and there will be plenty of indications of how things are going. If things are going well there wil be pressure to buy prior to the end of the trial in order not to get scooped by competition.
But you are right. If combo results are bad or just ok. That will hurt SP in short term and probably prolong any potential buyout. Meaning dilution to some extent will be necessary. I could be mistaken but hasn't management already given us an amount needed to complete both trials and it wasn't an extraordinary amount? As I have said before if you are in this game and afraid of some dilution, you are in the wrong game. The real dilution will come if CYDY tries to take to market. But management has indicated they do not wish to take to market alone. Meaning they will sell at a certain price if the drug works.
2Q or 3Q 2018*
Fred - how do you plan to play the game if PE is good. Assuming SP spikes will you take profits and risk missing buyout or ride out it out?
Actually, I'll just pose that question to the whole board.
As for me, I am tempted to take some profits if in fact the SP does spike but probably won't in case a BO does happen sooner than I think. My take is that the SP will spike and the slowly creep down as we wait for the next PR about full enrollment in mono. I share the same timeline as some others in that I think buyout is 2Q or 3Q event with some dilution some (but not excessive dilution in between). But interested in hearing others strategies for the upcoming events.
Thanks, gestalt. Appreciate the back story. Crazy that it ever got up to $4 when the developers even knew it would be such a long road. But $20MM of nondilutive money is a pretty big check in the pro column.
While we are all just waiting for PE... I know many on this board have been following/investing in CYDY for a very long time. Looking back at the SP charts the stock has been up to $4 and $3 in 2011 and 2012, respectively. Does anyone know what was happening at that time to make it spike and was it just delays that brought it back down?
*hole. Damn autocorrect. Gets me everytime
Thanks.
Also each situation is different. Understand people have been burned but if CYDY has the data to support the move and has momentum with mono that mitigates the risk of being forced to delist (which is the big risk with RS). I assume Tony is smart enough to only RS if he has an ace in the whole. Doesn't strike me as a guy who would RS just to uplist without having strong data.... wouldn't surprise me if they RS if data is awesome. With good data that would keep shorts away. They would be to scared of a buyout.
But agreed if we don't have great data that's the only way a see a big risk in RS. It just accounting magic that is often used by troubled companies but there are plenty of reasons a solid company could effectively use them.
Obviously some people don't get it... that would be you. Stock splits have no impact on the % ownership... you would get the same amount in a BO all else equal.
How is it dilutive? I get that troubled companies do R/S to stay above water but that seems irrelevant to CYDY.
Why not in favor of R/S split? Doesn't affect current ownership, and raises new money at higher stock price (I.e. Less dilution for same amount of funding)? I'm not trying to be a smart ass, just wondering if I'm missing something...
Hyperbolic - 6 months at $20 SP seems very unlikely to me with where the various trials are. The only way I could really think that is a possibility is if BP had competition for BO and there was some sort of bidding war. Any insights on whether there are other players at the table at this time?