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We have some irons in the fire:
FDA could respond re: monotherapy March 19
Shareholder meeting today 18th
Orphan Status response by March +- 23rd
BTD status by March +- 23rd
ASM MICROBE acceptance (not positive this one)anytime?
Trading has to pick up today or Monday
Chump
misiu- Nice! and thanks!
Amatuer17-you mentioned peer reviewed. Biotech protocol isn't my area. I do remember maybe on the Yahoo board this being brought up and covered. As for me Pro-140 isn't being independently company trailed but by multiple different locations all coming up with the same results. That's a plus to me.
Chump
Well that was impressive and positive. 140k shares traded in 10 mins and with uptick. Just hope the seller is finished.
Chump
I meant to add that proof to myself that the selling is coming mostly from one individual is the 83k on the ask @ .77. If it was multiple sellers the SP would be more alive than it is.
Chump
Just my opinion but I still think that someone or a firms position is being removed. If it was the dilution factor or bad news the SP would have fallen more rapidly than it has the last week and half and a whole lot more vol. Maybe we'll be clued in at or before the March 18 shareholder meeting.
Chump
Amatuer you're spot on with key milestones and news killing the SP with biotechs. I agree with misiu $2 and off this exchange. I would expect CYDY to rev up their investor relations with anticipation of March news. Crank up the PR's and a rode show. 18 days till the 23rd. Any day!
Chump
misiu143- I'm not claiming to know. My thoughts though it's been low vol selling thinking it's an individual or a firm. If it was high vol selling 7-800k+ then maybe bad news was leaking out. I'm picking up little bits-low hanging fruit. Sheen will help the SP if/when he reports reduced viral loads. The masses will like that. Favorable orphan and BTD results will take the SP to new trading prices. The larger investors will like that.
Chump
If it was dilution yesterday we would have fallen back and stayed put. I really think someone got taken out yesterday and had a little bit left today. Especially yesterdays last trade of the day 42k block below the bid.
BTW- dilution without anything pressing is negative. Dilution because the results are promising and needed to fund to the finish line is positive. Same as a split which isn't happening.
Some news next week on Sheen, Orphan status or BTD will solidify the value here and head north.
Nice back to back vol days.
Chump
WallStreet- not to sound repetitive but I think the RS is not on their radar now but do agree RS + results = happy shareholder.
I'll still have the same amount of money invested just fewer shares.
Hopefully in their March 18 shareholder meeting they make a mention of no immediate plans of RS. That would be a huge indicator of good to come.
I believe you called a pull back to fill the gap around .90. Good call or dilution? Who knows. The vol was good.
I expect much more positive to come re-Sheen..hopefully next week.
What I am pondering is if pro-140 can eliminate the spread of a disease while allowing treatment to target ex: a cancer tumor could this be utilized in areas other than HIV?
Chump
Thanks, not mine either. Just a hunch. Why? because we have the results you emphasize and I agree CYDY needs. Suppressed viral loads, no toxicity and no side effects. It's working. I'm just waiting on the FDA to issue approval. This is more in your expertise. I don't think CYDY would request BTD and hope they get it. I would believe they crossed their t's and dotted the i's beforehand. And throw in the fact that Sheens DR is on board. It adds up. For the SP trading today...on the OTC this crap happens all the time. On another exchange it will be more transparent and logical. Another result I'm wishing for.
Chump
I don't think it's the dilution factor. IMO it looks like someone had their position taken out. Also, I do not think they will do a RS. With two FDA responses due out any time should carry us above $2 long enough to move off this exchange. I'm betting against a RS. I don't want to sound like a pumper, I just feel confident they've reach a place in time that will carry the stock with it. Maybe next week??
Chump
Nice email! Thanks for sharing the info
Chump
Charlie Sheen effect:
http://www.cnn.com/2016/02/22/health/charlie-sheen-hiv-awareness-research/index.html
Chump
I went on the OZ site. Wed is about his anger management and divorce but there is a good possibility OZ could throw in... "did you meet the enrollment criteria for treatment"?
Chump
CYDY filed for Orphan Drug Designation back Dec 22, 2015 for the (GvHD). Does anyone know the timeline for hearing back from the FDA?
and
Jan 22nd they filed for BTD. I know that's a 60 day window for the FDA to respond (March 23rd).
It seems we're close to hearing on both of these filings.
Chump
dakota12 Thanks!- What does it do for the stock? On the pink sheets and eventually more dilution to pay for the trials?
Chump
Thoughts? CYDY has scheduled a shareholders meeting March 18 to increase shares to 250M. IMO- to provide funding for the trials which are extremely expensive which could be offered to a credible insti to fund these trials. Could it possibly also be to avoid a takeover/buyout?
So close to the March 23 deadline to hear from FDA on BTD. Do they think they'll have an answer before the 18th? I do!
Also, regarding the OZ show. I personally think that the FDA has no problems with it for one reason they don't want people flocking to other countries for exotic treatments. Half of their battles are combatting Non-FDA approved snake oils as true with vitamins/supplements etc.
A long week end to ponder.
Chump
Yes, I can't either-PPS. I know right now were on a stubborn burro.
Maybe let the masses digest the last couple days.
Chump
A positive article. There's many on the web now.
http://www.edgemedianetwork.com/entertainment/news/193330/charlie_sheen_discusses_possibility_of_taking_pro_140_for_hiv
Chump
Forbes article. The HIV community has a very strong political backing in Wash. The show wasn't a SP rally. Charlie and many more are in need of a new form of treatment. Everything discussed was factual. The BTD results will obviously benefit the SP which is due out any day till March 23rd.
Chump
This is copied from the FDA's site- BreakThrough Designation Guidance
" The accelerated approval pathway has been used primarily in settings in which the disease course is long and an extended period of time would be required to measure the intended clinical benefit of a drug. For example, accelerated approval has been used extensively in the approval of drugs to treat a variety of cancers and human immunodeficiency virus (HIV) disease where an effect on tumor growth or viral load can be assessed rapidly, but demonstrating an effect on survival or morbidity generally requires lengthy and sometimes large trials because of the duration of the typical disease course."
And
'Examples of surrogate endpoints that FDA has used to support accelerated approval include the following:
• Prolonged suppression of HIV viral load in plasma has been shown to reduce the morbidity and mortality associated with HIV disease and has been the basis for traditional approval. Shorter-term suppression of viral load has been used in the past as a surrogate to support accelerated approval because it was considered reasonably likely to predict an effect on morbidity or mortality. Data now demonstrate that short-term suppression of viral load may support full approval, in some circumstances.'
I agree with misiu143. Results will be our long term catalyst.
With that point- Dr OZ has to be ecstatic to have Sheen as a more than once guest.
Hopefully Sheen meets the trial criteria and gets his first injection in a week or so. A week 10 days out they check his viral loads and again OZ reports them. If viral loads are down and another 2 weeks OZ reports the same will be enormous press for CYDY. In the meantime the FDA gives BTD, another good. For today I was glad to see we didn't pop this am but had a gradual increase with the SP.
Chump
Been reading the posts here for about a month before chiming in. Folks here have done well covering the topics. Thanks! I think ultimately CYDY wants off this exchange. A lot more money would trade into the stock from non retailers if it wasn't on the pink sheets. March 23 is the deadline to hear from FDA on BTD. So really any day we could hear. A Disney scenario- BTD comes out and we hold over $2 and we move to another exchange. Otherwise a RS is the only way to the bigger money. If they RS and had BTD already, that news alone would offset the RS and the stock would climb. Of course only my opinion. I certainly appreciate the input here.
Chump
Nader P is sitting next to him.
http://www.doctoroz.com/episode/oz-exclusive-charlie-sheen-heads-mexico-and-comes-face-face-doctor-who-claims-he-has-cure
Chump
Charlie Sheen and CYDY CEO to be on Dr. OZ tomorrow.
Good luck. My first post!
Keep up the great posts.
Chump