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fine- I'll take the once a week SC no side effects vs a standing appt with hospital or nurse for punch punch for a quick 0.5log10 reduction. A no brainer.
And I will add tomorrow as it stays at these levels. Something that will not last.
Chump
This ole man will add heavily Monday. FWIW
Chump
Todays PR might as well have been written by the FDA. CYDY needs to understand that their PR's need to reach a variety of audience base.
I get it but I think many didn't.
What did I get?
You can't call a BLA meeting if your results aren't hitting the mark. The BLA PRE-meeting is your results are positive enough for us to sit down and discuss the BLA process and how we want your submission. We will meet throughout the process until all info is gathered and you will formally submit all accumulated info for final BLA approval. Otherwise you will drag this out to eternity with missing info.
So I am very positive of the GUIDANCE meeting but highly dissatisfied with the PR.
Next I would hope CYDY has financing or partnering on hold contingent on this Pre BLA meeting and FDA saying yes let's move forward with the process.
Which they did.
Chump
I have an open eye for Paulson. They should be more than well informed with CYDY past, present and potential progress. Most likely signed NDA's prior to the raises. Yes, NDA's
What was exhibited to the potential new buyers?...and how have they participated in the shares exchanged post the raise...Who accumulated those shares? Yes it's an OTC but complaints will be addressed by the SEC.
Chump
misiu- yes I remember some discussion here. Thank you!
Chump
Maybe another op for Pro 140 being autoimmune disorder (Lupus). I'll leave the findings to some of our physicians on board here.
Also, if so maybe raise finesands eval of CYDY higher. Kindly!
https://www.reuters.com/article/lilly-study/lillys-lupus-treatment-succeeds-in-mid-stage-trial-idUSL4N1TF4S0
Chump
coldterdinv- I'll take the #7 spot.
Chump
finesand- BLA, Biological License agreement and NDA, New drug application fall at the same meeting. I am very certain prior ASM knowledge of data for embargoed release for ASM today spurred CYDY early for a meeting with FDA. Approval, yes approval to manufacture and prescribe is in process as we post.
Chump
ahab333- As always from your posts, thank you!
Now from a blind squirrels see of things.
"Continuing access to PRO 140 is provided to patients completing 25 weeks in the trial."
wish they could pr their sentiments-
and
“With the highly favorable efficacy results for this combination therapy trial, and data from our previous trials and our ongoing monotherapy trial, we are now working toward the filing of a Biological License Application, or BLA, with the FDA for PRO 140 in the combination therapy indication,” added Dr. Pourhassan.
Since this data was embargoed prior to the meeting but on the agenda prior to the ASM, I would assume some time ago... BLA meeting or appt of meeting is near to a PR.
The elephants should be lining up at the door.
Chump
Broker57- I think the r/s dribble falls on the BOD's.
Saltz- I'm not concerned..just PO'd at the process. The warrants are being sold by Paulson from the raise participants .50 no risk and Paulson is buying them for other clients at the same time. That is why we always have a buyer and seller in this range. But yes, eventually it will dry or news will lift it.
Chump
If it is Paulson.... raise to a group of clients, sell off immediately for profit then have another client interested and buying and buy for them hence the constant pressure on selling but always a buyer in there.
Chump
tommyt- Thanks for your support here. Patients would've been more delayed for treatment if not for your investment and believing in CYDY/Pro-140.
Overall good for everyone.
Chump
tommyt- I think you meant "nobody" not anybody. Understandable, I remember when I had my first beer. Cheers!
Chump
nt2- If there was anything of concern I think Charlie would be the first to shout. Science is done here.
IMO- Dosing and FDA's blessing is our wait. I'm not a physician..an old guy that feels that dosing opportunities in trial is very positive. How high can Pro 140 jump?
Chump
Coldterd- Evelyn Woodhead might help you. The PR is very elucidating.
Chump
D0lp- thinking of quitting myself. Having to get up in the middle of the night to relieve myself. My age... sleep is becoming more important.
Chump
finesand- I believe if you contact Ms Thompson directly she might fill the blanks drmt@mindspring.com per "The return of PRO 140, a CCR5-directed mAb" prior or forward April 27.
Chump
tonysd57- Bravazo and good luck with CYDY.
Chump
Misiu- Can I assume more prophylaxis use with GVHD than HIV? and thank you and finesand.
Chump
gestalt2- yes and maybe I'm jumping the gun, finesand or misiu might add in but seems pro 140 might become a first line defense treatment so patients don't fall into the "failure category" while aligning a regimen.
Certainly has a fit with treatment.
Chump
Coldterd- Note: to CFO.. so far 100 against.
Chump
misiu- save it and I'll bookmark it as well. Cause another will drift in.
Thank you, good post as always.
Chump
misiu- yes..for those in doubt, suffering, and praying. This is more than an investment.
Chump
misiu- thank you but I believe you are right, (as usual). As you have made clear, Our quasi competition flew threw FDA with limited patient count..side effects etc. an olive branch to FDA for Pro 140 out their door. They will and hopefully this month break bread over CYDY and do as they should.
Chump
Misiu- I wouldn't want to be a higher up within the FDA with the current admin. A matter of time I feel.
Chump
I_luv_cydy- Proxy meeting was pushed from June 5th to 7th not the ASM.
Chump
d0lphin- now they can get back to their box of donuts. BTW- proxy out today pushed back meeting 2 days to accommodate you.
Chump
misiu- another and be sure to click on interactive map on left and pdf info on right.
https://hivdb.stanford.edu/
misiu- this one as well on HIV resistance
http://apps.who.int/iris/bitstream/handle/10665/255883/9789241512848-eng.pdf;jsessionid=EAB86F290F3FA1204BAF5181A93D25F9?sequence=1
Misiu- you might find helpful.
http://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf
tonysd57- you cheated (I wanna know how.. lol) but congrats!
Chump
Amatuer- timeline? You're the one always late blaming it on the rain.
You will hear about it though.
Chump
Emergcy- Then be happy because you are wrong!
Chump
tonysd57-Good gracious currently Justify 3-1 My Boy Jack 30-1. We'll take you out around #9 furlong. 40-1 like a lotto ticket.
Good luck!
Chump
beeandhc- I almost spilled my toddy. Nice post!
Chump
Misiu- You've dealt with the FDA and I agree that what has been done in such a short time is commendable. I'll take the JC Penny suit wearing CEO's with true passion over the flamboyant other bio stars any day.
Guess we'll see. My moneys hard here period.
BTW- many here really value your med input and adds truth to what CYDY is doing better Science wise for HIV treatment than any competitor.
Chump