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I imagine the data is ready, but they are waiting for a couple more catalysts before they PR bomb. It shouldn't take any longer to compile the data they have for 40 patients. My best guess is that combo enrollment is on the verge of filling and they want to PR that with data so we have a timeframe when the combo trial will be completed.
A little more patience is needed here!
The threat of an HIV pandemic is multi-pronged. Education on existing ART will help, but compliance will always be an issue for a toxic, daily pill regimen. If you have the option of a daily pill that will make you sick or a weekly injection that has no side effects - I think anyone's answer would be obvious.
Interesting article originally in The Westside Gazette about ART resistance and compliance:
http://www.lifeextension.com/news/lefdailynews?NewsID=27400&Section=Disease
It's actually .65 with .75 warrants now. They had to reprice it because of the SP.
Doesn't yesterday's PR potentially lend more credence to PRO-140 as a monotherapy treatment?
You have 11 out of assumingly 11-13 people that had undecetable viral loads after the 25 weeks and 10 people that rolled over to continue therapy.
Are we to believe/assume that these people would not be able to attain undetectable viral loads without the HAART in addition to PRO-140?
Just a thought.
The combo study has 2 arms:
https://clinicaltrials.gov/ct2/show/NCT02483078?cond=Pro+140&draw=3&rank=11
Active Comparator: PRO 140
PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy.
Placebo Comparator: Placebo
Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy.
So after 1 week, all patients are on PRO-140
My rep at Paulson framed it as if a raise is by no means imminent or definite, just possible (if not likely) and he would keep me posted. Thus, no terms were discussed.
Just got the call from Paulson and they are "likely" going to do a raise in the near future.
Says the girl who harped on the rebounders in previous trials. This company is nothing without stellar results which will further de-risk this investment.
Everybody is everybody that holds a share in the company. There's no action because we're between any sort of PR from the company. Or were you expecting a pre-revenue biotech on the OTC to trade in the millions each day?
Everybody is sitting and waiting in anticipation for PE results.
I think the FDA denying ODD on the basis that the drug has a broader application should tell you a lot on where they stand on the potential future labeling of the drug. Results will be the ultimate determining factor though.
Exactly. If PRO-140 can stand on its mono feet, you're looking at a multiple billion dollar market which makes dilution in the 10s of millions of shares not as hurtful to the potential multiple one could get on a BO. If the drug can only prove its use through combination therapy, the market is still in the 100s of millions/year.
The only thing I can think of is that if they PRed last patient injected it wouldn't equate to as large a pop in SP compared to compelling PE results. PRing last patient would give a hard timeline when PE results would be available giving shorts the opportunity to bring the SP back down before PE is released. If you simply PR PE results and not last patient injected and the results are compelling, this may result in more shorts being caught off guard and a higher SP pop.
This pretty much sums up my feelings on the company.
However, on the topic of the convertible bonds, I still don't see why Tony would pony up $1M of his own money without having a ton of confidence in PRO-140. It may present an alternative to himself if the company does go belly up, but why take that risk?
I think ideally the company would like to bring mono across the finish line because that is the real money maker. However, you're talking about a pre-revenue biotech that will have to continue to dilute to raise funds to see this thing through. Additionally, the company does not have the staff or resources to bring the drug to market themselves. I think the strategy is complete as much of the trials as possible and hope for a bidding war amongst the big pharma Giants.
On a personal note - anyone else sick with anticipation for PE results?
I believe that in addition to reducing the amount of patients required for the combo trial that the FDA also reduced the number of classes of drugs that the patient had to show resistance to. Originally, I think a patient had to show resistance to at least 1 drug in each class. I'd have to look back at previous conference calls to confirm this. If I have time, I'll take a look.
If combo results are enough to raise the SP for an uplist, or even if there is a RS to uplist, the amount of money the company would receive from the exercised warrants would be enough to power this company through the mono trial and then some. All depends on how compelling the results are and obviously how the market/investors react to it.
Thank you!
Go ahead and short to your little hearts desire!
I doubt they would postpone a significant event like enrollment completion or PE results because of the raise. When I participated in one, there were multiple PRs, and the SP was above .75.
This feels like a run-up in anticipation to a PR coming out about completed enrollment or PE data being released. Hopefully we are close and continue this momentum.
Form D just filed. Hope they don't miss their enrollment deadline again...
"We are on track to finish enrollment by the end of June." -Dr. P
For all of those people whining about a lack of insider buying. Is 1M significant? Or desperate need for funds?
8k is out. Looks like favorable terms to me versus what the current SP is. Granted that the company was diluted, but would one expect to see a bump in price given the SP where the raise took place?
Simply states that "enrollment is ongoing".
Abstract and presentation time info for CytoDyn for the ASM conference:
http://www.abstractsonline.com/pp8/#!/4358/presentation/6520
Hope you're right, but .50 is shakey right now.
I see this thing going down regardless. I can't envision a scenario where they get 30 adjunct patients before they have to do another raise.
I see now - thanks.
Where in the 10Q does it explain what this ct order is for?
I only see that it was filed today at 9:35 today. Haven't been able to look much more in to it.
CytoDyn just filed for a confidential treatment order. Can't wait to find out what this is about!
Haven't they been recruiting for combo since November?
52 week low is $0.54. After more delays and more dilution necessary, don't be surprised when this tests the 50s in the coming days.
This thing is cooked tomorrow. In to the .50s we go. It's mind numbing to me that they can't find 30 patients in 6 months.
I believe it to be CYDYs phrasing; however, they can't exactly lie about why it was not approved because that would be misleading investors. Maybe they're looking for some short volume today/tomorrow and will present great news for shorts to have to cover after the CC.
It's definitely phrased in such a way to make it seem that PRO-140's potential is far superior than receiving ODD.
I participated in a raise that closed early 2015. This is the second event I have been invited to and I have also been contacted by representatives for Paulson. Based off of the 10Q which was just released they should have ~5M cash on hand (that's assuming they burn about 2M/month). Unless there is a BO on the table, they will have to start the raise now so they have more money before their current cash supply runs out. Really hoping for some good news on the CC - interesting that they put out a reminder for it.
I participated in a Paulson raise and was contacted also... it's looking like they are going to do another raise. The SP is going to take a beating. Hopefully the CC delivers good news with enrollment.