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JACKSONVILLE, Florida, November 17, 2017 / TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced its Chairman and Strategic Advisor Glynn Wilson, Ph.D., and Senior Director of Molecular Biology & Virology Robert Florkiewicz, Ph.D., will give an oral presentation titled, “Increasing the potency of DNA-based immunotherapies using PolyStart™ peptide expression system,” at the World Vaccine & Immunotherapy Congress West Coast, held Thursday, November 30 – December 1, 2017, at the Loews Coronado Bay Resort in San Diego, CA.
Yes I know. Keep up the good postings on $ELTP.
Pharma Sleuth, Couldn't have said it better. Always a pleasure to read your posts on $ELTP.
"Ya Gotta Believe"
The one year later refers to ixCELL-DCM
"We successfully treated the last patients in February, 2017, and the last follow-up visit will occur approximately one year later".
Vericel is directly linked to 3 bone studies using ixmyelocel-T
Here are all of the ixmyelocel-T 8 studies
https://clinicaltrials.gov/ct2/results?cond=&term=ixmyelocel-T+&cntry1=&state1=&recrs=
Studies 3, 7, & 8 are bone studies
Cell Therapy for Craniofacial Bone Defects
https://clinicaltrials.gov/ct2/show/NCT01616953?term=ixmyelocel-T&rank=7
UofMichigan and Vericel are directly linked
$VCEL Piper Jaffray Healthcare Nov 29, 2017
29th Annual Piper Jaffray Healthcare
Home / Investor Relations / 29th Annual Piper Jaffray Healthcare
Nov 29, 2017 2:00 PM EST
Cat Whisperer Thxs for that info. MACI IMO will be standard at all ARMY USA Medical centers. Only a matter of time, if not already, MACI will become the US Army's knee regenerative procedure throughout it's International medical centers in Europe, Asia etc.
A lot of politics in the USA FDA. Criminal bribes etc, by the established approved Pharmas where a new medical therapy would be disruptive. I wish it were otherwise in the USA.
Pres Trump campaigned on quicker approvals and Dr. Scott Gottlieb his chosen Commissioner, were suppose to change this and and approve after Safety and efficacy were established. This should be Phase2B. So what happened with $VCEL's Ixcell DCM very successful P2B? Why is a P3 needed b y the USA FDA????
Chinese ICT want it, and it is now up to China CFDA to approve. +5 yrs on a Phase2b and absolutely safe. Those in the Clinical that are still there, their lives continue.
The FDA wanting a Phase3 is totally difficult to understand. More lives will be loss that could have been saved with Ixcell DCM.
toofun appreciate the good humor. A lot of shareholders know the value here and are adding to their $ELTP portfolio.
Yes it is going on and off-line all morning and still being shown as "not issued"
Yes it does as Elite has both names. The warning letter of 8/25/2016 was addressed to Elite Laboratories
It is being taken off-line and then returned to on-line this morning. It has happened several times this morning. It depends when you look.
I have seen the FDA list the new approvals before the CEO PRs the Material Event. It is not clear IMO why this happens at times. The question is:
Is the official Registered FDA Clearance letter on its way for delivery?
Elite just removed again. This means that the FDA is taking Elite off-line to work on it IMO.
Brown's Compounding Center just got clearance letter Nov 14, 2017. $ELTP is listed next. Brown is shown at Nov 14, 2016, however probably mean't to be Nov 14, 2017 as everything else on that page 6 is 2017 clearance letters.
You are correct in that it is at times not listed. Something going on.
FDA special task force at work preparing for the change to state date of clearance letter.
It is there now. It wasn't before.
Elite's warning letter of Aug 25, 2016 is not listed this morning on either Page 5 or 6.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/default.htm?Page=6
agree
Yes as there may be updates on ICT and China
It is very common to examine the safety data by the FDA before proceeding forward with the trial.
Yes for sure.
Piper Jaffray $6 tgt and IMO $VCEL will have an excellent presentation.
That is a good question . However the bigger "prize" for China is to quickly approve $ELTP SequestOx for Commercial application based on the very successful $ELTP P3 163 person bunionectomy which had ZERO Adverse events and therefore proven 100% safe with very high efficacy. There is zero Tmax issues in the real world.
Yes. I am thinking that $VCEL trained surgeons already have scheduled MACI procedures for the Army center.
It means IMO that it is a go already
Award will be made on or about 14 November 2017.
Gman24 Yes there will be a percentage sharing of the bottom line. However at this point cash funding for new ER ADFs trials etc. will be NH target, and that is where there would be revenue sharing with the new Partner.
The upfront cash infusion directly to $ELTP now from the Partner would be used to fund current R&D operations for new ANDAs filings.
In Partnership negotiations those of us in the Pharmas firstly look for synergism between the two parties. That takes awhile to find. It depends when NH seriously undertook a search. At the CC he stated that he has to consider again the possibility of a Partnership. This to me means he has a lot to do in weighing the possibilities , which could take weeks.
However $ELTP is patiently waiting for the FDA ADE SOPs clearance letter and each call to the FDA, as to does the FDA want anything more from $ELTP?, is responded to be patient.
So we wait. With the official FDA ADE SOP clearance letter in hand, it becomes a new ball game.
It hasn't been easy on anyone and understandable. However some shareholders have use this opportunity to add more $ELTP shares to their portfolio.
Total nonsense. $VCEL is now cash rich.
Very much so. Purdue has very deep pockets and already has approval of their Oxycontin in China.
However NH is waiting for the FDA ADE SOPs clearance letter. There are zero issues remaining as $ELTP has cleared up all remaining issues for the ADEs SOPs and the required NJ site handing facilities and procedures. The FDA Apr 2017 site visit was simply old issues dating back to 2016 that had already been cleared up in 2016. That is why NH has stated there is nothing remaining for $ELTP to do for ADE SOP FDA compliance.
no2koolaid A very well thought out scenario of Partnering. Certainly SunGen and Humanwell/PuraCap/Epic have already entered into Partnerships with $ELTP. However NH is thinking about a more in depth Partnership. It could be with SunGen, or Humanwell/PuraCap/Epic or a new Partnership with yet a 3rd Group especially those with deep pockets.
Agree Dan is clearing the warrants out which is necessary for new Partnerships.
Absolutely. Everything is on the table. Dan O'Connor had negotiated terrific several partnerships at ADXS. That is what the Dhillons want from him.