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Agreed but I think the following was a summary of a cc done last yr; it'd help a lot if we had past cc transcripts. Either way you're right. Currently I'm looking towards combo therapy as that's up first. Thanks.
2. Ph 2B (hindsight) – Based on the new screening method, the failures would have gone down from 18 to 2 – Going forward this method will be included in screen patients for phase 3 (for CCR5 patients)
3. University of Pittsburgh - New assay method – This new method can identify lowest level of viral load.
This method used on 3 patients blood samples – 2 patient have ZERO viral load (big news) and 1 patient had 1.2 copies of viral load per ml (suppression is defined at 50 copies per ml) – 8 samples under testing – 8 samples from extended therapy will also be tested. Company will not say they have cured HIV (even after ZERO viral load) but will present data after all the patients samples are tested at Pitt and let others comment on the results.4. Existing Phase 3 trial – Adjunct therapy trial
Took this from seeking alpha as I was trying to find an old conference call transcript. Seems like this mentions what you were alluding to.
Edit: 8 were vaccination related issues in the company's belief. From what I can gather it was a combination of vaccination/r5 screening for other patients as per past cc. It's clear that finding the right biomarkers is key as we know it works for certain people coupled with a more accurate screening method.
Good questions and explanations. Not sure where jboat got the "five patients" from. It's become clear to me that this issue was addressed multiple times in past conference calls that are not all available to newer investors. Perhaps the 1yr+ investors may know and will chime in. For now, I believe the November 2016 Investment Community Presentation has everything you're looking for. They start talking about it around the 14-15 min mark iirc. Thing is you can't really skip ahead otherwise the slides get messed up. (Be sure to look at the full chart. You'll know what I mean.) As per the data set, it appears that 8 out of the 18 failed were screening/vaccination related issues. The company realizes how crucial the biomarkers are and will share more info soon. This was a very informative presentation to any new investors. You should really give it a look.
http://www.webcaster4.com/Player/Index?webcastId=18420&uid=3487322&g=bb4da319-f315-4de5-bbe7-bd7ec0b9cce1&sid=
Imo it's not about being able to pull off a BO or not. It's about the price perceived amongst long time investors vs board members coinciding with the offers laid out on the table. Perhaps this needs to be clarified at some point. For now, I'm content with 100% of the company's focus towards p3 results because without that none of this matters. But yes at some point the sp needs to be addressed alongside some sort of plan towards bo/partnership/getting product to market. This is a 5 employee run company and to get this far is commendable but there are limits. And maybe this has been addressed already but I doubt it because otherwise it'd seem that management would be getting ahead of itself. For now I'm just happily accumulating. Personally, I wouldn't mind if it drops more as I can see the games being played. I expect the gap to fill at some point in the coming months as well. Whether it can hold will depend on p3 results.
Heyy CYDY fam. I'm beginning to understand why there are certain sentiments behind the stock and company based on where we are at. From the info I've gathered last night, I can tell the ceo, Dr. P is very understanding of shareholder's concerns and has an open door policy in regard to communication. With that said, he's not a pump the stock/finance type of guy albeit he has raised an excess of 70 million to pursue pro140 and brought the drug to two ph3 trials all within the confines of the OTC. He doesn't play around and is all about the data. And that's good enough for me for right now as someone looking to invest. If you want volatility and lots of volume, this isn't that type of stock. There are plenty of big board stocks or etfs I play around with for that.
It was just received not too long ago that the initial 300 to 150 to now 30 patients is the new requirement for the combination therapy p3 trial. This versus other trials like Maraviroc which required 500 patients with over 2 years worth of data. Combo therapy primary endpoint was reduced to one week, VL < .5 log, and the allowance of safety data usage from mono therapy was received as well. I wonder if some of the people here actually realize how many hundreds of millions of dollars and time was just saved. Probably more than $300 million imo. The original 12-14m combo cost for p3 should now be drastically reduced as well. But more importantly, I think the key takeaway here is that this move speaks to the confidence the FDA has in pro140, its data, and its willingness to work with Cytodyn.
Now with the topic of insider purchases. Rule 10b5-1 prohibits insiders to buy/sell stock on non-disclosed/non-public information. So if folks are hoping for a buyout/partnership anytime soon, this would present as a conflict of interest. This is one of the things I look for in a possible buyout/partnership scenario that meets my timeline.
From what I can gather, we should be getting big news in a couple of months. In fact this is a catalyst filled upcoming year for CYDY, the biggest year probably since its inception.
Lmfao
<3 Thank you for your kind words but I can already tell some of the folks on this board are more experienced than I am. This is a good board. The way I like to see long investments like this are in 3 fold: science, fundamentals, technicals. I can already see the games being played on the chart as I believe the chart never lies. Ofc in the long run, none of that may matter. I'm currently catching up with the science and fundamentals portion whenever I have extra time on my hands.
So your original 12/11/2016 estimate was calculated on the premise that mono therapy p3 trial would not happen? That doesn't make any sense. I'd love to see how you worked out the calculations if you don't mind. I'll try to take a look at the filings more in the coming week.
3 million, combo primary endpoints (edit)
Congrats to anyone that picked up cheapies. I picked up some myself as well.
You posted the same thing on 12/11/2016 and that was before the offering on Monday. 4 million has been added on so I would think another few months should be added on to your original 12/11/2016 estimate. There are a few catalysts in between that we can look forward to. Off the top of my head there is the orphan drug designation filing, last patient enrolled for mono, begin patient enrollment for GVHD, update on the 10 patients who have successfully achieved complete viral load suppression for more than 2 yrs, and mono primary endpoints.
It's become clear to me I have to look over the filings of shares/warrants again. The jump conveniently coincided with the timing of the presentation/offerings while someone seems to be painting this chart like Picasso. I'll be adding at key levels as these are seemingly gift prices.
Hm as for the details of the trial, other than using clinicaltrials.gov, many companies don't go into elaborate detail with their trials on the front of their pipeline page or in their PRs. Take ORP$ for example as I saw it was mentioned on this board the other day. Take a look at their webpage to see how well they go into detail about their pipeline and trial procedure. It's a joke. Coincide that with their $11 IPO in 2014 to its price currently and the fact that their management hardly ever communicates with shareholders. My point is that this is my first time with CYDY but I'm actually impressed with how they've been able to get to two phase 3 trials of a multibillion dollar drug and not kill the stock price to death. And from what I've seen the communication is better than most companies, especially in the OTC. There are many biotech companies presently on the OTC that are trading at 000s or at pennies. As for the limited number of employees, it's a double edged sword if you ask me. Otherwise, you'd be asking for tremendous amounts of dilution which is a word investors shudder to hear. Simply, you can't have your cake and eat it too.
For the adjunct "combo" therapy, I believe it was stated that primary efficacy endpoint results from the pivotal phase 3 combination trial could come as early as the first quarter of 2017. Iirc, it was originally a 300 subject study which was reduced to 30 subjects/26 weeks study. The combo therapy contingent positive results is worth billions. The crown jewel of course is the mono therapy which is what I think you may be confused with.
Good morning CYDY fam! Love the prs today. Just checked them out and added more to my position. I like how the ceo outlines a timeline/plan moving forward. Communication is important; there are too many companies out there that leave investors in the dark. I'll check back in later today. Hope you guys have a good one.
Thank you! Some of your previous posts about the science and 5top, jboat, and saltz chats about the SS/playbook have been right on the money. Couldn't have explained it better myself. Actually they explained certain topics succinctly enough that I just got a clearer understanding. Looking forward to doing more DD over the weekend as I need to read up on the sci and ss alil more.
Funny thing is from my experience with ihub or just about any chat, once it gets crazy, all the weirdos come out. It's just how it goes. Happy to see we can have alil bit of peace & informative conversations while some of us get to accumulate more here.
Heyy there. I recently started a position here this morning. From the initial amount of info I've gathered, I'm excited to say the least. I've read a few comments and I'll probably do more DD over the weekend but we've got a great board here. From scientific explanations to the finance/share structure of the company, I've actually learned a lot in general and picked up a few things as well. Happy to be aboard. Just figured I'd stop in and say hi.