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I agree with the AE perspective..However, would you rather abandon Haart and Die, or deal with SE's..some not as debilitating as others. Remember, Nadar wants to Know why Pro 140 did NOT WORK in a percentage of patients...that is called viral load suppression and trial efficacy. In other words, they were withdrawn from the trial as efficacy failures..Nothing to do with AE's and SE's.
If this ever went to .70 cents, I will buy dinner for the entire board in Chicago..central location. Most expensive joint we could vote on...Just dreaming..but seriously..I would in a heart beat!!
Why has the EAP not endorsed the Beads? Let's start there. Unmet disease state (Sepsis)..well on their way to probable prevention of death, But the FDA still says "NO WAY!" It certainly isn't efficacy..they may die anyway. It has to do with proven safety. Fear of premature death due to bead infiltration perhaps! Again, the EU uses Surrogate endpoints, without Morbidity/Mortality large scale trials...safety is there, but Not a huge data lock. The FDA simply wants reliable, credible and valid large scale data for both efficacy and Safety...You know this...but are baiting the susceptible Newbies. Who should they believe, the non adopting EU docs who have full approval and the FDA that says NO...Or..You and Salesman Chan..Think about the investor's decision..No Brainer!
I am not talking anyone away from Adjunct...that is very high probability and could bring an unprecedented BO from the likes of GILD. So even if there is a chance of failure, I am holding through Adjunct. I also think we will get the HIV Naive, but may not get Mono. Either way..Off label in an unmet disease state with the AA, FDASIA and CURE act. BLA by Q4 for Adjunct 4 to 8 Billion!
In an Official PR directly from Nadar...Not Me!
We expect our Phase 3 monotherapy trial will provide essential data to support the continued clinical and regulatory advancement of PRO 140,” added Dr. Pourhassan. “We will use the findings from this trial to evaluate biomarkers within the R5 strain that could identify likely PRO 140 responders versus non-responders. This may provide valuable information in determining which patients will achieve long-term HIV viral suppression with PRO 140.”
I believe Mono is very unlikely. I believe the CCR5 MOA has a degree of synergy and Haart will always be needed as as synergistic Viral Load suppressor. I do not believe PRO 140 SC can ever go it alone..at least according to the preliminary data. If 20 to 50 % can go Mono fine, but who will ever take that chance without all the protection out there available.
This may provide valuable information in determining which patients will achieve long-term HIV viral suppression with PRO 140.” OUCH!!
This may lead to another dosing/frequency Pro 140 P3 trial!
Misui...the data I presented is right in front of your eyes! With each weekly interim of data, comes a corresponding loss of responders/Efficacy. Dr. P. has already conceded to trying to figure out why there are non responders in the Mono study. He has stated that in print and verbally on various CC's. I will attach a verbatim statement from Nadar...on my next post via CC.
We now have 10 that have sustained viral load efficacy/rebound at 2.2 years...about 50% of initial study participants...good, but 50% experienced resistance similar to Haart regimen.
Well and good..not weel and good.
That is all weel and good. However, there is no sign of traction with the PR's or PPS!!
Does Pro 140 also share in the same resistance Pharmacodynamic and Pharmacokinetic profiles as the Haart regimen. With every designated week interval, there is a corresponding loss of viral load efficacy...see below:
Results from the initial 14-week treatment substitution monotherapy trial (which excludes
viral load failures due to patient screening errors) are as follows:
98% of the patients passed 4 weeks of monotherapy
91% of the patients passed 6 weeks of monotherapy
82% of the patients passed 8 weeks of monotherapy
70% of the patients passed 11 weeks of monotherapy (maximum allowable
monotherapy without an extension study)
14 patients, who were offered to continue in an extension study with this
monotherapy, are approaching 6 months without experiencing a viral load rebound.
Is this the resistance issue we are combating with Haart...Just curious..TIA
Thanks for your Input Amature. Below is a list that I believe may come from an investor venue..I think the biggest bang for the Buck is Croi, only a month away.
1) Formal Initiation of GvHD Trial
2) Another NIH grant ..Slim..but possible
3) Partnership..slim..unless primary data is in, but I believe weeks too early for that yet. Also, primary end points would be best served at Croi Venue!
4) Hopefully as you suggest...At the very least, P3 Adjunct Enrollment completion...Huge!
5) Mono enrollment update..hopefully ahead of schedule..which will be huge
6) Here is an Off the map positives my critical Lil birdies...FDA reduces Mono "N" just like Adjunct "N"..Highly unlikely..but cool to think about. Nadar has always said there is an Extreme pent up demand for Pro 140 so the efficiency and expediency of getting 300 enrolled may be worth the relatively short wait for a stronger "N" going into FDA assessment and evaluation. So N =300 may be better than N = 100 for power of Data (especially if it only takes a few more months!)
gestalt2: I am trying not to be negative, just Balanced. Here are the types of posts that rub me wrong while holding a speculative Bio Tech:
Lil birdies are absolute..many here will retire in a few months MARK THIS POST
First of all look at the number of OS and secondly, look at the scale of the studies and how long ago they were...and where we are now..Huge disconnect!
Share Structure
Shares Outstanding 3,026,680,967 a/o Sep 30, 2014
Float 650,000,000 a/o Jun 30, 2009
Authorized Shares 4,950,000,000 a/o Sep 30, 2014
Par Value 0.001
Company Information
About Lifeline Biotechnologies:
Lifeline Biotechnologies, Inc. (OTC Market: LLBO) founded in 1994 is based in Reno, NV. LLBO has invested over $10M in a device and process for early detection of breast tissue abnormalities some of which are cancerous or pre-cancer. Three “Proof of Concept” clinical trials of over 500 women have been completed and three patents (one hardware, two software) have been awarded. http://www.lbti.com
BTW...I am far more interested in where we stand at the time of Croi, than I am at tomorrow's investor conference. I believe Nadar is simply setting the stage (no pun intended) for the new year and for Investor and Shareholder communication.
I have learned to be cautiously Optimistic in Bio Tech...been burned too many times. Just went through a 9 to 12 month set back in another Bio tech where all the Pumpers were 100% sold by the CEO and Company. Sooo..what do you think will come out of Nadar's presentation? Completion of Adjunct, Initiation of GvHD, NIH grant, Partnership with GILD, BO, 50% Mono enrollment (all positives, so there!) OR....Do you really think this is the Venue or Format where something very significant will be announced? Perhaps...just wondering what you think will be announced? And..I am being Serious! TIA
Can you believe that the "Widow Maker" LAD is often times 90% plus atherosclerotic and stenosis has left only a 10% or less run way. Many are asymptomatic even with that level of stenosis until a small innate blood clot or coronary spasm finishes the job. Also, have you considered "Many" beads piling up. However, you are correct, the LAD is one of the largest circulatory arteries that would be compromised. RCA, renal, Hepatic and stroke even make my point more significant. I do believe the Aorta and femoral arteries are safe :>) Your..Beloved..Pearsby
I have measured enthusiasm and expectations regarding tomorrow's presentation. First of all, the Milestones may just be a reminder of upcoming projections in the entire year of 2017. So we may not hear anything new, or we could even hear of some possible set backs and delays. This is an investor conference, not a clinical conference, so Nadar may just be trying to harness more exposure to his company. As to the Timing being Thursday, I am neutral. Remember, this was only a four day work week for most company's. I believe anything of clinical significance would be presented at Croi in Feb. Let's hope we have adjunct completion and Primary endpoints by then. I hope I am pleasantly surprised tomorrow, but it smells of advertisement more than progress, completion and execution of clinical trials..with possibly the exception of an announcement of imminent GvHD initiation/enrollment.
Thanks Chump..appreciate it..I missed that!
Where did the PR state "MILESTONES"?
Myocardial ischemia due to LAD occlusion...a serious threat that could manifest and precipitate Myocardial Infarction morbidity/Mortality! Your..I only Care..Beloved..Pearsby
Did you all consider the Filters that house the Beads cost less than a dollar per column. .77 cents to keep the Beads at bay..Really! Think about the risk once we get real "N" exposure! Your..Only But Loving and Caring..Beloved..Pearsby
I am assuming some upbeat news on a Thursday vs. a Friday! JMHO
Awesome! Hopefully some good news! Thank you for sharing.
We have 7 trials in our pocket, which gives me solid optimism. However, the historic P2 to P3 failure ratio makes me a little skittish. Just trying to keep it somewhat real. I am long CYDY..very Long!
Change, what I find interesting is that LLBO talks about a majority owner in Circadia, However, Circadia has the main web site ..LLBO a very invisible entity.
Saltz..I hope you are correct...But I have a 70/30 probability on the Adjunct outcome..which is still quite Optimistic in light of the P2/P3 historic follow through's!
Circadia will suck us initial long term investors dry! And why not...cause they can!
Also, without an extraordinary Q4...more capital needed for Chan's 50 studies..i.e. Dilution! Your all caring and Beloved..Pearsby
I hope Chan can finally unveil some real DATA! Walstreet has him pegged. Anymore case study venues and I think I will Puke!
I agree Change..this is a PINKY/SPECULATIVE/LOTTERY play! With a Cheesy CEO and constant unmet Deadlines...PINKEYVILLE>>OUCH!!
I agree Change..this is a PINKY/SPECULATIVE/LOTTERY play! With a Cheesy CEO and constant unmet Deadlines...PINKEYVILLE>>OUCH!!
They have a manufacturer in place for the EU, Asia and India, but not enough for the masses...then there is reimbursement issues even if proven and available...PINKY!!!
My point is: who would ever go on Pro 140 Mono, if it fails in adjunct, with the assistance of Haart. If Adjunct fails, Mono will be scrapped!
Something to consider. If Adjunct fails...why continue with Mono therapy! If Adjunct fails, Mono is dead in the water...and Gvhd is only an excuse to keep the ship a float for 1/20th of HIV market potential. The Autoimmune will be smothered, just like Mono if N=30 Adjunct fails. We have already seen 50% of Mono fail over two years. Adjunct may need Haart's help, Mono left for dead if Adjunct fails...Just a thought.
Lucky as Hell Story. Back around 2008 a bought several 100K shares of a POS stock called Sponge Tech (Pinkster) . It went from .03 to .28 within 4 hours. Thankfully I was by my computer and pulled the trigger. It went back to .06 in a day or two then disappeared off the Planet as a scam. However, I will not tell you about the MANY that were not so friendly to my portfolio..too long a list.
Some talk about it was .025 in 2010...Big difference. The OS was much smaller...dilution City since and a much larger OS now (Billions..Yes, Billions, not Millions) Secondly, this is no longer a LLBO baby...Circadia will slice off the majority of gain...if that even happens..Again, Big difference since 2010 days. However, at least it is still alive vs. Totally dead for 5 years. Perhaps thinking .005 will bring about a more proper perspective and expectations...still a 6X gain from today.
Volume = 1 share! Is that even possible? I guess so...I wonder who the lucky recipient/Seller of that 1 share is...please speak up for bragging rights!
"Can never have too much shares."
Oh yes you can!! It's called too much weight in one equity. However, if this goes to 8 plus, then you have a point.
In fact, severe sub Penny Land!!!
I hope you are correct..But not Holding my Breathe!! Penny Land!!