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RS is fine, so long as it is paired with positive news about trials or other news. I can't imagine that CYDY management would do this unless they had some "bullets" ready to support and drive SP. That said, this is, as many have stated on this MB, a binary investment and one which has required extraordinary patience. The positive Combo results have derisked the investment from a long term perspective, but obviously not from SP downside risk in the short term. I do think that moving up to a better exchange will bring in new institutional investment funds increasing the chance of SP appreciation during the wind up of the Trials and improve the BO or JV opportunities.
Spoke with Investor Relations representative and he confirmed that the PR was written to be sure company was aligned with FDA. While the representative could not tell me anymore than the PR did, IMO the amended protocol request is the result of positive trial results, as previously stated by others on this MB.
Agree, they need to clarify why they are requesting the change. The release is problematic and open to broad interpretation/speculation, as to the Interim Results.
Well said, agree with your post, CYDY is well positioned with lots of runway.
IMO a "deal" in 2018 is the most likely outcome assuming continued good trial results.
You raise a valid point regarding ongoing enrollment and announcing PE results. It was/is my understanding that an Interim PE efficacy analysis would be done and available. IMO confident we will be receiving positive news this month.
Woodenbear, sorry for the delayed reply, but I was not at my computer. I am not a Moderator, but a long time shareholder with a serious investment in CYDY. Regarding the number of enrollees, I would be shocked if they had less than 50 patients, however, full enrollment may be a moving target, so one could say, enrollment is not complete. As far as I am concerned, management is doing what needs doing and I am confident that shareholders will be receive positive news soon.
Appreciate your reaching out and feedback. Thank you!
Understand your point of view. It is hard to just wait on a binary invested like CYDY, as there is so much riding on the Combo PE. That said, I believe the recent posts are reasonable and essentially accurate.
I am confident that full enrollment of at least 50 has been reached. As for the other items, I leave that to other Posters to answer.
Looks like this MB has gone dark That's a shame because PRKR has hit a bottom IMO and has a shot to rebound quite strongly. Just need a little good news and with such a small number of shares, the upside is relatively high.
Good to know there is at least one more "fan". I've been spreading the word about INSG and would sure like to see this MB build more followers and post volume.
More than awake, as I believe INSG is on the verge of emerging from the best kept secret in small cap tech companies. So many positive developments, terrific new management, products, services, and major corporate customers and partners. Investors who conduct their DD will be impressed.
It took my company 12 months to close a BO where all parties agreed to price and terms from day one. So not surprised with the news "blackout", as NDA violations can be very costly. That said, I have been invested in CYDY for 3 years and I am ready for a resolution, hopefully, one which confirms my decision to invest in this company.
Possible there is a BO LOI on the table which is covered by an NDA. We shall see soon enough.
Agree with you Gestalt. Additionally, I think they have injected at least 50 patients and are in the process of analyzing the data. It is also possible that they have not unblinded the Trial and are going beyond 50, just in case they are needed.
IMHO, we are very close to learning PE results.
Scoot, IMO your conclusions of what the IDMC statement means are correct. It is possible with the release of data achieving PE targets that a BO or Joint Venture is announced, as well. If all 50 subjects have been enrolled and treated, I would think that we will know something within a few weeks.
IMO, the omission of the termination provision was a legal blunder in the initial offering. That said, the new offering contains the termination provision and is a more effective call to action. Is the risk/reward of an extra $0.25/share really justified? Why take the risk when,if PE targets are hit, the reward will be tremendous anyway?
I was puzzled about what the meaning of the IDMC recommendation, so I googled "What does it mean when the IDMC recommends continuation of a trial". Reading about several cases revealed that virtually every time the recommendation was made to continue the trial, it was because the results supported the eventual achieving of the PE goals. I think a reasonable conclusion is that the Interim Results were on target and that news of BO or joint venture are not fanciful, but realistic.
IMO we will be receiving positive news no later than mid January.
As one of those Buyers, I am continuing to accumulate until PE data is released, which I believe will be positive and happen within 30 days or so. Prior to that event, I don't expect much will happen with the SP, one way or another, as long term investors are holding. As I have mentioned in the past, this is a binary investment and will be a serious winner or bust. See it as a 10 to 1 upside potential profit vs. $.60 risk, all or nothing.
IDMC recommendation reflects their assessment that interim safety and efficacy data analysis are acceptable. Here is a quote from their website, as to the committee's responsibilities. "An independent data monitoring committee (IDMC) or data and safety monitoring board (DSMB) can play a vital role in protecting patients enrolled in a clinical trial from harm. An IDMC may also review of interim efficacy outcomes in trials with early stopping rules or adaptive designs." Since there is no "early stoppage or adaptive designs", my conclusion is that this is great news regarding safety and excellent news regarding efficacy.
Low volume could also mean SHs are not interested in selling. That said, the lack of awareness of this stock does limit the buyer pool. Positive PE results and RS with up-listing should attract some institutional buyers and
result in a significantly higher SP and BO interest.
Agree, RS paired with good PE Results should result in increased strong SP increase.
Individual Investors are the primary supporters of CYDY and as such are holding because the overwhelming history and sentiment is that the PRO 140 Trial Results will be terrific. Once that confidence is confirmed, I expect new buyers to emerge, SP to move up, and CYDY management to announce a RS timed to benefit from the good news.
Great post G2, agree 100%.
It will help, but how much we will probably find out on the CC next week.
Yes, they will have to unblind the study to do the interim efficacy analysis. As others have said, good results derisks the investment and then its just a matter of time before BO or other positive event.
I don't think enrollment will stop, in fact, it should be easier to enroll given more patients will be meet Trial Criteria.
CYDY does the Interim Analysis not FDA. Management can report results and if good, will positively impact SP. BO potential and company's ability to raise funds to complete all the Trials underway. I could be wrong, but results should be known in a matter of few weeks, at most.
Efficacy is the key and within very short time we will have that information. Assuming the Interim Analysis is positive, the other changes are not significant. That said, I wish the PR had stated when the Interim Results would be reported. The Conference Call on the 19th would work for me.
FDA "...can conduct an interim efficacy analysis of primary endpoint." Very good news and the key to the future IMO.
Newmike, you are correct.
Agree 100%, company will be sold by year end. Many have speculated as to the price, I won't. That said, I am very confident current SH will have an excellent ROI.
Excellent News. PR states the facts and they are all positive. If there were negative results, they would be obligated to report those, as well. IMHO, discussion with FDA on October 17th will result in expedited pathway to BLA. Results increase the chance of a BO or JV getting done, sooner than later.
Agree, the double-blind has not been removed, so results are unknown. Very smart for management to get FDA's agreement to close the Trial, results will soon follow. If positive, we're all going to be very happy, if not,
look out below. BTW, every reason to expect results will we good.
IMHO, there are offers on the table pending Combo Trial Results, however, not in the $20 range. Given historical Trial results, a strong case could be made for an early BO in the $10 range, maybe slightly higher, if results warrant. Not saying it would be accepted, especially if CYDY has attractive financing lined-up, but could happen.
Very important article from Reuters regarding HIV Resistance to current drugs and the importance of PRO140 to address the needs of these patients.
http://www.reuters.com/article/us-health-hiv-resistance-idUSKBN1A51TG
Yes, assuming the premise is true, I would think SP support will continue as long as there is high confidence the Trial results will confirm PRO 140's efficacy.
Agree, SP being supported for capital raise pending trial results.