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Looks like this bit of speculation sparked a rally. I'm anticipating news in the form of a PR Monday or Tuesday.
Perhaps some "unofficial" news over the weekend even.
IMO
Jesi has made her Facebook profile private. What do we make of that?
Perhaps at the request of NVIV?
Unless we have missed news elsewhere it must of been a hell of a report.
$20 is how much the research report costs. Not a price target.
Dr Langer is on the board for Ocata therapeutics who are developing a stem cell platform technology with some pretty impressive IP. They also have a there own "superstar" doctor in Dr Lanza.
I'd love to be a fly on the wall to hear what these guys chat about over coffee.
https://www.ocata.com/about/leadership/board-of-directors
OLD - SORRY
Is it March already!? Lol. I see that now. I feel a little foolish. Sorry all.
Either way I feel like this is a last ditch effort for some hedgies to get in on the cheap before imminent positive news.
Short attack on my opinion.
This will bounce back some this afternoon. Especially once the new hire news gets out. Vary positive IMO.
http://www.pharmavoice.com/newsreleases/invivo-therapeutics-appoints-lorianne-masuoka-md-chief-medical-officer/#
I would think so too.
News
http://www.pharmavoice.com/newsreleases/invivo-therapeutics-appoints-lorianne-masuoka-md-chief-medical-officer/#
InVivo Therapeutics Appoints Lorianne Masuoka, MD as Chief Medical Officer
Source: InVivo Therapeutics Holdings Corp. (NVIV)
February 9, 2015
February 09, 2015 08:00 AM Eastern Standard Time
CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Lorianne Masuoka, MD, as Chief Medical Officer (CMO), effective March 2, 2015. She will be taking over for the interim CMO, Lou Vaickus, MD, who is also Founder & President of akta Pharmaceutical Development LLC, a life sciences consulting company.
Prior to joining the InVivo team, Dr. Masuoka served as Senior Vice President and Chief Medical Officer at Cubist Pharmaceuticals from July 2013 until Jan 2015. As a member of Cubist’s executive management team, she managed over 150 employees in the areas of clinical research, drug safety, biostatistics and data management, and clinical operations. Prior to her time at Cubist, she served in various roles of increasing responsibility at Nektar Therapeutics, including Senior Vice President and Chief Medical Officer from August 2008 until August 2011. Dr. Masuoka served as Vice President, Clinical Development at FivePrime Therapeutics from July 2003 until August 2008. Prior to that, she served as Director, Clinical Development, Oncology at Chiron.
Dr. Masuoka has a medical degree from the University of California, Davis, where she also completed her residency in neurology. She completed her epilepsy fellowship at Yale University and has a board certification from the American Board of Psychiatry and Neurology (Neurology).
Mark Perrin, CEO and Chairman of the Board, said, “I am very pleased to have Lorianne joining the InVivo team at such an exciting time in our company’s history. She will be instrumental as we transition from executing on the expedited timeline for our pilot study to designing our pivotal study. Her medical background in neurology and extensive experience in clinical development, managing early to late stage clinical trials in neurological indications and many other multidisciplinary indications will make her an invaluable asset as we move forward with our current and future clinical programs.
“I also wish to acknowledge the excellent work Lou Vaickus has done at InVivo since joining in late 2013. He successfully partnered with a team of clinical and regulatory experts to initiate our first clinical trial. In addition, during his tenure as CMO, he led a close collaboration with the FDA to greatly improve the efficiency of the first-in-man study by expanding the number of allowable clinical sites from 6 to 20, expedited the enrollment plan, and enrolled our first two subjects in the trial. Lou was also an integral part of the leadership team in a range of corporate activities, such as our corporate financings.”
I had one more buy in me set at $2.2. Didn't expect it to get filled. And it did as I was typing this.
Back up now please. :)
I always wanted more. But I never thought I was going to see the low 2's again. Man was I wrong.
I've doubled my position in the last two days. what a gift.
Is this referencing our hydrogel? Or a new/different venture for Dr. langer?
http://www.fiercebiotechresearch.com/story/langer-team-offers-hydrogel-drug-delivery-vehicle-mit/2015-02-24
Great read thanks for posting.
Can you tell me the date that was originally posted and perhaps some background on the poster, stemdynasty if any is known? For example is he a long time holder / retail investor, or does he represent a VC firm or other institution of some sort?
I'll read again to see if I can pick up on any context that might answer my questions. But appreciate any insight you can share.
Thanks again.
This "article" is ridiculous. It just throws financial metrics into a boilerplate and is likely automated to a large extent.
It's similar to ESPNs fantasy football "match up comparisons" from week to week where the computer just plugs in info and spits out a short comparison based on your line up projections.
I doubt anyone thinks someone is actually writing that for every single fantasy participant. This is no different IMO.
We all know that you can't base a buy/sell rating on a developmental biotech based in earnings or revenue. So this kind of "analysis" shouldn't fool anyone.
This was just a way to throw INO into a negative headline so the shorts can pile on.
Long INO. Waaaaay long it looks like now.
Nope. I sold 1/3 of my position a few months back around $10. Was looking to pick it back up once I had some more biotech bucks. Never thought it would go below $8.
Certainly not selling down here. But probably not buying either.
Just looked back through some PRs and couldn't find that reasoning mentioned anywhere.
Sill interested in others thoughts on which leadership structure is best for an up list attempt. (Unified or independent CEO/Chairman position)
Thanks in advanced.
Way back when didn't Frank relinquish his roll as Chairman in order to create an independent board as part of an up list attempt? I might be misremembering.
I understand the pros and cons of both. But which structure is looked upon more favorably in terms of up listing in your opinion? And more importantly which does the Nasdaq favor?
Perhaps they have already filed? They were told they would be given a expedited review. Maybe they are waiting on the actual approval so they can release back to back PRs. Or drop a bomb in one.
You never know. Any reason this couldn't happen, legally speaking?
You are talking about this being the first time for this particular scaffold construct in the spinal cord correct?
The synthetic polymer, the material the scaffold is made of itself has previously been used in other in vivo applications right?
Thanks for clarifying for me.
Not sure if the Scaffold Plus Stem Cells would require its own line of trials. Hopefully someone could comment further on this?
"InVivo Therapeutics has announced that the company is realigning resources behind its novel Neuro-Spinal Scaffold and the Neuro-Spinal Scaffold Plus Stem Cells program for spinal cord injury (SCI)."
http://www.invivotherapeutics.com/2014/06/invivo-therapeutics-announces-realignment-of-rd-strategy/
I don't believe so in the following pivotal trial due to it being fast tracked for commercialization as a device. But that's the end game for NVIV for sure. And this news gets us that much closer to that reality.
"InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE)."
Great post. I appreciate you breaking that down.
Absolutely. Aside from Jordan wiggling his toes, this is probably the best news one could hope for IMO.
Enrollment for patient 2 pushed up. Then concurrent enrollment after just one month of patient 2 observation. This is fantastic news for investors and SCI patients alike.
Correct me if I'm wrong but the biodegradable polymer used has already been proven safe to use in patients in previous studies. So this is really just double checking that it works the same when placed in the spinal cord.
Lets get this trial done and move on to the exciting stuff with stem cells. Which is now potentially 1 full year sooner. IMO that's when miracles start happening.
Great suggestion.
Today is day 60 correct? Perhaps we'll hear some news about Jordan's progress.
In my experience a developmental stage bio saying they have sufficient funds for at least the next 12 months is the norm regardless of their cash position.
From the last 10Q:
"As of July 31, 2014, we had cash and cash equivalents of approximately $37,900,000. We expect these funds to be sufficient to allow us to continue to operate our business for at least the next 12 months."
One quarter later they have $34m that's a burn rate $1m per month. I believe Punit said somewhere that number will raise to $1.6m per month in 2015 coming to $19.2.
So sure raising capital is likely as is always the case with a pre-revenue company. But not anytime soon. And I too imagine the PPS to be well above $1 when that time comes.
I agree as well. I suppose in the back of my mind I always felt those statements by Kim that Pistol pointed out were indeed just a strategy to ink more favorable terms in a deal.
Now reading Pistols august comments within the context of this most recent filing, where there was no mention of a partner whatsoever, going it alone seems likely. And I'm ok with swinging for the fences.
But can you imagine how the PPS would react if Kim pulls a juicy partnership deal out of a hat when no one is expecting it.
Now that the share price is stabilized maybe he's gaming investors a little to create the most dramatic rise in stock price with a surprise partner?
Now that's a little far fetched I know. But fun to think about.
Actually NVIV isn't really a good comparison at all. That stock dropped all the way from 5-6 due to the previous CEO and co-founder Frank Reynolds essentially misleeding investors on the time line of their flagship program and hyped the stock relentlessly. He was also heavily invested and was selling 12mil shares every day for months. (A number of reasons were speculated on)
During the free fall Frank was shown the door, restructured their clinical trials shelving a promising stemcell hydrogel approach for treating chronic SCI in order to cut burn rate and focus on their scaffolding device. Eventually having a secondary offering around 1.15.
The recent rise is due to them finally getting the first patient enrolled with early results looking good and the FDA loosening up requirements slightly for subsequent enrollments.
So there was good reason for that roller coaster. ONCS up and down and hopefully back up are all riding the wave of basically the same info/promise.
The only correlation in my mind is that they both have possible breakthrough treatments with notable doctors on the team. That's where it stops tho.
Yeh I know that Dr. Kim has always said they will keep an eye out for a partner but willing to go alone. Just sounded a bit more definitive to me this time.
Your probably right about decline being due to the pennvax-gb delay. A few months is hardly something to worry about in my opinion tho.
I'll have to read through the transcripts of the conference call later tonight. But judging by the PPS rebound people liked what they heard.
My thoughts are that the PPS decline is due to the company stating their intentions to tackle the VGX-3100 phase 3 alone. And will need to raise funds to do so.
I'm not sure that is a revelation of any kind. But also don't remember seeing it in writing anywhere before this.
I could be wrong and am interested in others thoughts too.
Long INO and will be buying dips throughout 2015 until I'm fully loaded.
I think the FDA approving the addition of 14 more test sites (20 total now allowed), as well as loosening up the restrictions for enrollment (slightly) says a lot about what has been observed thus far in terms of safety with the procedure.
Him being all action is no understatement. In the almost 4 months he's been here we have:
Secured $30Million from Lincoln Park Capital
Executed a 1:100 Reverse Stock Split
Added Dr. Langer to the Scientific Advisory Board
Bolstered our IP
Announces fantastics results published in The Lancet
Name Change ... I'm sure I'm forgetting stuff as well.
This morning he floats the platelet partnership idea out there. Now makes a key hire in the newly created position of Chief Commercial Officer. And to someone who has an extremely impressive background at that.
I'll be voting YES. Don't you all want to see what Dr. Wotton is capable of once let off his leash?
He's been spot on too so far.
According to the charts what comes after 12.50 is what I'm interested in knowing/seeing.
That's what put AGIO on my radar as well. But what's with all the insider sells?
All the more the more reason Punit needs to get this first partnership done right with the most favorable terms for ONCS. It will set certain precedents for all that follow.
Take your time and get it right in my opinion.
Absolutely.
Partnership brings more benefits near term than just the cash savings IMO. So that's definitely what I'm looking for. Even if that means giving up a piece of the pie down the road.
Yeh I read it as they are leaning towards going it alone.
"we are excited to NOW have the opportunity"
As if the opportunity wasn't there prior. It was. But as a partner only... right?
But now, now we have options. Which will only help our negotiating position if a partnership is still in discussion.
But if we end up going it alone just purchasing the PD-1 we will likely need some more $$.
Am I putting that all together correctly?
Can we get a sticky of this post mods?
A lot has been made of the timelines outlined in the 10q. But after reading the transcripts of the call it seems to me that Dr. Kim is just trying to do a better job of managing expectations. Better to under promise and over deliver. So being conservative in their guidance is the right play. Even if the PPS takes a hit in the interim.
Imagine what the PPS hit would be if they said VGX 3100 p3 to start in 1h15. Come July AF would be putting out hit pieces and people would be jumping out windows.