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RALLYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYy
breakout coming
Get in now or miss the train ...
Dip is a great buying opp
Looks like clsn will run up fast today
Really ?? Lol just wait a few minutes
In a few days you which you bought at this HUGE bargain level
DNDN was at 3$ too !!!
Bids coming in
The train leaving the station...
Breakout coming if we break 3$
It could happen any minute
Big Rally coming
Load up folks
RALLYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY
Watch here please lol
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=IPCI&mkttype=pre
Get in NOW before its too late .
UP in canada again
Bid is at 4.20 in canada = 4.42 in US$
Load up the truck while its still wayyy undervalued .
Its still peanuts wait till Phase 3 results then watch this rocket flying like Dendreon into double digits .
IM VERY OPTIMISTIC ABOUT THE UPCOMING PHASE III RESULTS .. READ THIS
The DMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the "SAFETY and EFFICACY data" generated in the trial.
Data Monitoring Committee Unanimously Recommends Continuation of Celsion's Phase III ThermoDox(R) HEAT Study to Treat Primary Liver Cancer
COLUMBIA, MD -- (MARKET WIRE) -- 02/11/11 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that after reviewing data from 482 randomized patients in its multinational, randomized, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radio frequency ablation for primary liver cancer (the HEAT study), the study's Data Monitoring Committee (DMC) has unanimously recommended that the trial continue enrollment.
WHAT IS DMC (Data Monitoring Committee ) ..
The DMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the "safety and efficacy data" generated in the trial. On a regular basis, the DMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.
Still a fantastic buying opp
Wait till FDA approval or Partnership then you will know why
Again load up the truck before the major news coming
double digits coming
FDA approval or Partner Deal and this stock will hit 10 dollar and more in no time ..
IPCI is still very cheap better get in before the big news hit the wire .
Another good day ahead ..
We could see 4- 4.50 this week
Still wayyyyyyyyy undervalued
GET IN NOW BEFORE ITS TOO LATE
New highs coming
Load up the truck while you still can
http://www.pharmacychoice.com/News/article.cfm?Article_ID=712828
This is the perfect time to load up the truck before the BIG News coming .
Phase 3 interim data + NDA submission + New Partnership all this News coming very soon .
See you guys in the Double Digits before year end .GLTA
.........
Some Slides from Cowen Presentation (March 2011)
Phase 3 interim analysis this Q
http://www.wsw.com/webcast/cowen3/clsn/2__Slide15.JPG
Rolling NDA + Priority review in 2011
http://www.wsw.com/webcast/cowen3/clsn/2__Slide6.JPG
Multibillion Dollar Potential for Thermodox
http://www.wsw.com/webcast/cowen3/clsn/2__Slide21.JPG
Near Term Milestones
http://www.wsw.com/webcast/cowen3/clsn/2__Slide24.JPG
Mega Pipeline
http://www.wsw.com/webcast/cowen3/clsn/2__Slide5.JPG
Liver cancer expected to be the Number 1 cancer by 2020
http://www.wsw.com/webcast/cowen3/clsn/2__Slide9.JPG
Strong Patent till 2018
http://www.wsw.com/webcast/cowen3/clsn/2__Slide4.JPG
Commercialization strategy
http://www.wsw.com/webcast/cowen3/clsn/2__Slide22.JPG
Financial summary
http://www.wsw.com/webcast/cowen3/clsn/2__Slide23.JPG
Hard fight on the 200 day moving average with the market maker bestards they tried their best to hold the stock down below 3.15$ .
IPCI must break 3.15 today then look out for a Monster jump .
The most people still not realise the MONSTER Potential in this Company but BIG Payday is nearing.
http://trondsworld24.blogspot.com/2011/04/celsion-clsn.html
Wednesday, April 20, 2011
Celsion (CLSN)
It has been a long time coming, but Celsion should be taking the big step forward within the next couple weeks. I have been screaming from the rooftop for weeks now that if you want a position, you need to fish or cut bait pretty quickly.
Presently around $2.30, by the end of June I am forecasting a price in the $5s or $6s. As soon as they complete enrollment in the HEAT trial, several cool things occur.
First, and most importantly, HEAT then gets a "shot on goal" - an interim calculation of how the trial is going. While interim looks typically are very low likelihood of showing statistical significance (and thereby stopping the trial while they apply for approval) from various simulations I believe we may have as high as 25-30% chance of such happening! But even if this does not occur, the final calculation will then be 8-12 months away - locked into a for-real timeline for final results. Funds and institutions tend to shy away from companies depending on interim calcs, but with a less-than-one-year deadline they would be more willing to invest.
Secondly, once HEAT is enrolled, they will immediately start enrollment in the next trial. Combined with the joint venture with Royal Phillips (HIFU guided Thermodox) they will then have three trials up and running in 2011.
Companies with a trial under an SPA, in a huge, unmet medical need like later stage liver cancer, nearing an interim calc should be trading around a $150M to 450M market cap. With Celsion currently listed as around $33M market cap, we'll be looking at a 3x to 10x increase in the few months leading up to full enrollment in HEAT.
Finally, once Japan's PMDA (FDA-equivalent) agrees to allow enrollment to restart in Japan, a couple more events occur. (enrollment was halted at a pre-agreed 18 patients for an extensive safety review - which is not yet complete)
Obviously, having Japan involved in enrollment again gets us to enrollment of 600 more quickly.
Forgotten by some is the fact that our Japanese partner Yakult pays us $2M at this milestone.
While holding through the interim calculation certainly gives the chance for a 20 bagger or more, an investmnet now, holding only into the near-certain runup into the summer should repay us with a double or more.
Regards,
Trond
NEW ARTICLE ....A MUST READ !!! Now you Know why this is a pure Goldmine .
CEO says multiple deals, FDA approvals and more filings are in the works
Thursday, 21 April 2011 01:02
As we first told our premium subscribers on Tuesday, the management team at Intellipharmaceutics (Nasdaq:IPCI )(TSX:I) is clearly excited about the progress they've been making. The pharmaceutical company specializies in the reformulation and manufacturing of novel and generic controlled-release and targeted-release oral solid dosage drugs and they are finally on the verge of going commercial in a big way. With multiple pending FDA approvals, we first profiled IPCI in detail in late January. The company caught our attention for several reasons. Among them is the fact that the reported sales for branded and generic versions of their pending approval products stands at close to $9 billion.
IPCI develops both ANDA (Abbreviated New Drug Application) product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway. Their CEO, Dr. Isa Odidi, is easily considered one of the sector's top drug delivery innovators. When Odidi was at Biovail- which merged with Valeant Pharmaceuticals International (NYSE: VRX)(TSX:VRX) in 2010, he was performing drug alchemy with formulations that mimicked several hard-to-manufacture generic versions of expensive drugs- among them, Pfizer’s (NYSE: PFE ) Procardia XL, Bayer’s OTC: (BAYRY.PK ) Adalat CC, and Novartis’ (NYSE: NVS ) Voltaren XR.
While serving as Biovail’s Vice President of Research of Drug Development and New Technologies he helped grow Biovail into a multi-billion dollar company. Now he’s doing it all over again, this time with his own emerging biotech-- and many see it as extremely undervalued, given the events which are set to transpire there. That sentiment is underscored by the fact that the company is close to FDA approval and plans immediate commercialization of those drug candidates.
One key clue as to the company’s intentions took place on On February 7, 2011, when IPCI announced that it had retained the services of Doll Consulting, LLC and its principal, David S. Doll, to assist with the commercialization of products. Mr. Doll has over 26 years of solid pharmaceutical industry experience in commercial operations, including a stint as Executive Vice President of Commercial Operations at Impax Laboratories from 2006 to 2008. Most notably, Doll successfully negotiated long-term agreements between Impax and several major pharmaceutical companies. Rumors that Mr. Doll has been working his rolodex to bring those same types of partnerships to IPCI led us to an eye-opening interview with Dr. Odidi himself:
CEO, Dr. Isa Odidi: We have 5 ANDA’s under review by the FDA at the moment, the last one was just announced a few weeks ago [On April 4, 2011 the Company announced the filing of an ANDA with the FDA for a generic of Seroquel XR(R) (quetiapine fumarate extended-release tablets)], Seroquel XR is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. According to Wolters Kluwer Health, sales of Seroquel XR(R) in the U.S. were approximately $800 million in 2010.]
We continue to work very hard to try to meet our milestones. Part of the Seroquel filling is one attempt in that direction to meet our milestones for this year. We were looking to file two products this year, we just filled the one and the year is still early, so part of that point is that we are performing so far we hope that is the case. We continue to work on many generic products where a few we are first to file in the midst of this. We are hoping that the year is very good. Work is progressing in regards to the NDA front, we have the first NDA, which we made public, Oxydocone XR is our Rexista(tm) technology, which is progressing well. We are also looking at 2 other products in that same direction, but we have not named them yet.
We are also looking at a once a day solution for a drug that is currently taken multiple times a day. That has not been named publicly either.
BioMedReports: Dr. Odidi, we’ve been hearing rumors that your company is very close to announcing partnership or licensing deals for some of those drugs. Can you discuss that at all?
CEO, Dr. Isa Odidi: We expect some licensing deals to be announced as well. The licensing deals might be two pronged, 1st to license one or more of the products we have currently in front of the FDA to be marketing to the US and rest of the world and secondly to piggyback on that- a co- development program with one big pharmaceutical player. That is what is happening. Obviously we are also gearing up to manufacture these products cause we expect these products to get into to market after approval- at least the Focalin XR, so we’re gearing up and we are preparing space and equipment to make sure the products can be manufactured when the approvals come. Quite a lot is happening.
BiomedReports: Can you tell us about the one big player. You said it would be a two pronged approach?
CEO, Dr. Isa Odidi: Yes, we should see some licensing deals announced this year. It will be a two pronged approach. First approach is licensing of one or more of the products we have currently in front of the FDA for Approval in the US market and the rest of the world. The second prong is to piggyback on one of these licensing deals where we would co-develop a product with one of the key players in the world.
BioMedReports: So you would be developing a product for them?
CEO, Dr. Isa Odidi: For them as well as well as pure licensing and marketing of these products.
BioMedReports: When do you think we might start seeing some of those licensing or partnership deals announced?
CEO, Dr. Isa Odidi: While I can't put a date and time to it, I can tell you that we are working as aggressively as we can and are hopping this is going to happen in the very near term.
BioMedReports: The other thing investors want to know is: When do you think we might actually start hearing something back from the FDA on some of these pending drug approvals?
CEO, Dr. Isa Odidi: The approvals for the ANDA's is an ongoing affair. We are corresponding with the FDA on a regular basis we have 5 products filed with them, so things are going back and forth between the agency and ourselves. It is typical of the process towards getting an approval done, so we are talking to the FDA on a regular basis I cannot tell you when we will get the approval letter, but I can tell you we are working aggressively to make sure that it happens and one point is the fact that we are already gearing up for manufacturing- so that tells you that things are happening. That’s the best that I can say at this point.
BioMedReports: Does the FDA get involved with things like manufacturing details- since the ANDA is a different process than the one facing new Biotech's filing new NDA's?
CEO, Dr. Isa Odidi: They don't get involved with telling you where the site of manufacturing should be, but they do come and inspect your facility. They have a pre-approval inspection of your facility that has to be done. We had the FDA here last December, so we are working with the FDA to make sure everything is in place for an approval to take place . In anticipation of that approval it makes sense to gear up and prepare for production and that is what we are doing as well.
BioMedReports: Yes we have been hearing rumors about that that you have been traveling and gearing up for production and scouting various facilities. I’m sure investors will be excited to hear that, but for those who are not as familiar with the company, could you tell us in your words, Dr. Odidi, why IPCI may be a good investment right now, especially at these prices? What is the value here?
CEO, Dr. Isa Odidi: I think our strength lies in our drug delivery technology we are also very strong in our ability as formulators and businessmen. We know how to get a business deal done. When you look at our partnership deal with Par Pharmaceutical (NYSE: PRX ) and the way we went about trying to raise money and all those things you’ll see evidence of that.
Secondly, we are able to make sure that whatever we are doing eventually meets its goals. That puts things out there for our investors to help see value. Having said that, I think that the fact that we have a small float is important to consider as well when one looks at us in terms of value for money.
The approach we have used is two- fold, the first part is to have a series of products that are first to file. This way we have exclusivity, and therefore big bang for the money.
The second approach is a fail-safe approach, where we are looking at presenting a basket of products sometime at the end of next year into the market. So when you’re looking at maybe 7, 10, 15 products in a basket set for FDA approval and to be marketed; even if we were to only make $10 or $20 million dollars in sales per product, it adds up to anywhere from $ 100- $200 million in sales. Now when you are looking at our small float, I think it presents very good upside for investors for the share price where we are trading right now.
In addition, we are not a one trick pony. We certainly feel that in terms of risk, people are not going to get in trouble in terms of expecting good return on their money- especially for this kind of company. Where else can you find a company out there that exists with this kind of operation, with a small float, with strong technology, with products that have already been filled with the FDA? Not many. We feel we are another Impax (Nasdaq: IPXL) in the making.
BioMedReports: Can you give us any idea about how you pick the drugs to go after?
CEO, Dr. Isa Odidi: I have to try my best to not provide competitive information, but I will try my best to answer you.
Obviously first to file opportunities are the first drugs we look out for. These drugs are moving targets. We have chosen them, as well as the competition, but a lot depends on who gets there first. We are also looking at blockbusters, products that have very good sales. In addition, we also look at products that are difficult to make (formulate), so there will not be as many competitors in the field. I think that is, basically, what we do. As far as targeting those difficult to make products, we have an advantage in that we have a strong technology platform which we can use to do just about anything. We can take any small molecule and give you any profile you want, that is not a problem for us.
So at the end of the day we are not limited by the science of doing the work. We are looking for something that will limit others from the standpoint of time. It is very difficult to make the products that what we want to go after. Last, we are working on the Rexista program, the abuse resistance technology. We, like many others, are concerned that people abuse narcotics, so for us it is a win-win situation. On the one hand, if we successfully make the product we make money for the company and the shareholders. On the other side, we are also helping solve a big social problem. So as a company, that makes us feel very proud.
BioMedReports: How are you feeling about the prospects to be able to meet your milestones? You have talked about, in the past, what you want to do; how many drugs you want to file per year, etc. Looking at your record, personally, when you were doing this with a previous company, you seem to have an ability to work at a very brisk pace. Do you think this is going to continue?
CEO, Dr. Isa Odidi: I think that it should continue, of course the regulatory steps and amounts of money you have to burn come into play. At the previous company you alluded to, we had hundreds of millions of dollars to spend. Here we have a very little in comparison, but people are surprised that with the few resources we do have, we are doing what we are doing. [On February 1, 2011 Intellipharmaceutics completed a sale of 4,800,000 units for gross proceed of $12,000,000.]
We just had some twelve million after the raise. That is not a lot for companies to even develop one product, but we are committed to filing at least two this year, and we have already filed one. So we think we are on track to do even more. Last year we did a lot given our limited resources. Last year the record we set was the same as the previous company you were talking about- Biovail. We were doing at least four controlled release products a year there. We should be able to do at least four here as well. It is not easy but we are working hard and have the science to bear and to do a lot of work.
BiomedReports: What are your biggest challenges that you see for IPCI?
CEO, Dr. Isa Odidi: I don’t see challenges, I look at it as a puzzle that you have to solve. It’s an issue of managing the change. We are growing rapidly and we have to be able to manage the change carefully. Given the resources we have and the fact that we think we can get to profitability next year, when we start selling Focalin XR. We have to manage change. We are at the point where we are ready to expand manufacturing given that we have 5 products (filed) with the FDA and many more to come. Also, we’re looking to expand the areas of Marketing and Commercialization. So far we have been able to manage all of that.
Come on lets push it over 3.15
The market maker rats tried to hold it down to steal more shares .lets buy some shares to stop their chit .
Major Breakout coming if we move or close over the 200 day moving average at $3.15 .
Load up the truck while its still significantly undervalued .gl
Buy with both hands because you will never see this low again
Volume and Chart means takeoff could start today . If we break and close above the 200-Day Moving-Average at 3.15$ then look out .gl
http://stockcharts.com/h-sc/ui?s=IPCI
Time to get in before its too late .
This monster stock will move like a brutal HURRICANCE once we get new like Partnership or FDA approval which could happen any time now .
A move up over 3.15$ will be super bullish for the stock ..
Up up and away and back to old highs
BIG JUMP IS AROUND THE CORNER
Rally is on the way
Partnership and FDA approval coming any day now .gl
Take a look at level2 indicates a huge run is around the corner
Load up the truck before the FDA approval or Partnership news hit the wire ..
Breakout coming any minute now
Chart gets better and better
Time to buy before its too late
GL
great buying opp
Partnership and FDA approval coming any day now .
Breakout is in the making just watch and learn
Back to 6$ very soon
I like no i LOVE this stock you have the huge opportunity to Buy IPCI at a Ridiculous low price . IPCI will move over 10++ dollar in the coming months . Again perfect time to Buy . Best Luck
Emerging Biotech Titan Loaded With Catalysts
1/21/2011 10:04:33 AM - BSR
Jan 21, 2011 (ACCESSWIRE via COMTEX News Network) --
Dr. Isa Odidi of Intellipharmaceutics (Nasdaq:IPCI) (TSX:I) is easily one of the sector's genius drug delivery innovators. While he was at Biovail, Odidi was performing drug alchemy with formulations that mimicked several hard-to-manufacture generic versions of expensive drugs- among them, Pfizer's (NYSE:PFE) Procardia XL, Bayer's (BAYRY.PK) Adalat CC, and Novartis' (NYSE:NVS) Voltaren XR. While serving as the company's Vice President of Research of Drug Development and New Technologies he helped grow Biovail through its adolescence.
As difficult as the scientific process was, the business plan was simple. Odidi and his team worked out the chemical composition to develop the drugs and pushed their versions through the regulatory process at the U.S. Food and Drug Administration. Once approved, the company licensed the drugs to different companies and collected royalties. While Odidi perfected his science and learned to navigate the FDA process, Biovail grew into a 10+billion market cap company.
You'd never notice him if you passed the Nigerian-born CEO on the street. Odidi is a quiet man whose demeanor and smile tend to understate his achievements and brilliance. His work has been cited in textbooks, scientific and medical papers and countless articles, but it was his work at Biovail that caught the attention of Wall Street after he first founded Intellipharmaceutics as a private company with his wife and colleague, Dr. Amina Odidi (an accomplished formulator and scientist who some often refer to as the company's Secret Weapon), in 1998.
Several financeers and investors with an eye for developing publicly traded companies recognized that Odidi and his unique talents as a master formulator might be worth a bit more than a paycheck- perhaps billions more. Through a carefully crafted reverse-merger in 2009, they helped take the company public and now, after careful incubation and lab work, it appears their bet on Odidi is about to pay off in multiple ways.
"We looked at what was happening in the generic space and we thought it was crowded by people who were doing things that were easy to do," explains Odidi when interviewed about the birth of his own company. "And so we tried to find a new niche where we could be competitive."
That niche was targeted and controlled released drugs using a proprietary Hypermatrix technology.
"As a result we are going after very difficult to make products," explains Odidi. "And the reason we chose to go this route is there are not many competitors playing in this field."
While most drug delivery companies deal in three-dimensions, Odidi decided to expand his vision and approach to drug composition by introducing a fourth and fifth dimension: space and time. "After all, we are in the time release business, so we should be looking at how to control time," says Odidi.
The result is what Odidi calls "super generics"- very good copies of drugs that are about to come off-patent and aim to make the original drug formulation better. According to Odidi, the technology allows him to deliver any active pharmaceutical ingredient to the body in the right amount at the right time.
As a result, Intellipharmaceutics has now filed approximately $6 billion of generic controlled released drugs with the FDA to date.
In anticipation of several key events, biotech investors have begun to buy up whatever shares they can get. Since we highlighted the company to our subscribers days ago, shares have nearly doubled and they look to go much higher for one simple reason. The float of available shares is nearly non-existent and those who have managed to purchase shares are simply not letting them go. The result is a developing "load and lock" investment play not unlike the one we saw when shares of a bankrupt Vermillion (Nasdaq:VRML) go from pennies to over $30 per share based on a single catalyst event- an FDA approval last year.
If you look under the hood, IPCI has a nearly identical number of shares outstanding and a growing number of hands that are buying as many shares as they can with both hands as they eyeball a list of multiple drug candidates and a stream of anticipated 2011 events that may fast track the young company into a generics powerhouse:
Pending approval of Dexmethylphenidate XR, a generic version of the marketed Novartis drug Focalin XR®, which IPCI partnered with Par Pharmaceutical. The drug is currently the subject of an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA). Because the Generic Division of the FDA does not issue PDUFA action dates, the timing for a decision on the company's filing for the drug is not listed on biotech catalyst calendars. Savvy speculators have started placing their bets, nonetheless. The patent litigation designed to slow the approval process was paid for by Par and settled last March (at the time, the stock ran from approximately $1.50 to $5 on news of the settlement. Today the stock is starting to break out beyond those previous highs).
Licensing deal for Effexor- a $3.8 billion brand sales drug that was developed by Wyeth and subsequently acquired by Pfizer is used in the treatment of major depressive disorders. The FDA accepted IPCI's abbreviated new drug application (ANDA) last May and credible sources tell ************* that several companies are interested in licensing the generic as they believe they can capture a healthy share of the market. Conservative estimates place that share at $600 million with potential royalty revenues to IPCI of $30 to $120 million.
Licensing deal for Protonix- a $1.8 billion brand sales drug that is indicated for conditions associated with GERD (i.e. ulcers). Just weeks ago, the company notified the FDA that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, Inc., a wholly-owned subsidiary of Pfizer, Inc. Investors now know that Intellipharmaceutics will not be subject to the automatic 30-month stay of FDA approval to market the product and that has potential suitors swirling to make a deal which could net them an estimated $450 in sales with potential royalty revenues to IPCI of $22.5 to $90 million.
Investors are excited about the potential NDA filing with the FDA for Abuse Resistant Oxicontin. Controlled-release oxycodone drugs had U.S. sales of approximately $2 billion and IPCI's drug delivery platform, branded Rexista is a novel dosage form (paste in a capsule) designed to be deterrent to the well-documented abuses - including nasal inhalation when crushed or powdered, and by injection when combined with solvents. In May the company advised investors that it had taken delivery of and fully qualified its primary manufacturing equipment for the manufacture of the abuse-deterrent formulation and that the manufacture of clinical batches using that equipment had commenced. It is worth noting that the company's Rexista technology is applicable to additional opioid drug candidates like oxymorphone, hydrocodone, and morphine. As the technical analysis chart shows, the stock is primed to continue running higher- especially when you consider that prices are now within acceptable ranges for institutional investors and funds who may have been either hesitant or simply unwilling to jump in previously.
Our Big Payday is nearing ..READ
http://seekingalpha.com/article/262302-biotech-catalysts-for-q2-2011
IntelGenx Technologies Corp. (IGXT.OB) in a 2010 year in review on March 30th noted that their NDA resubmission is “imminent” for their high strength antidepressant CPI-300. They note that since a patent infringement case by Biovail Incorporation was thrown out in February they are now free to resubmit the NDA after remedying the two issues that initially caused them to receive a complete response letter back in February 2010. In that CRL they were asked to address a “food effect” in which they now plan on a simple label change indicating that the drug must be taken on an empty stomach, and they were also asked to qualify their commercial manufacturing site, something they’ve claimed to have gathered data on and taken care of since. The key word on this NDA resubmission is “imminent”, per their March 30th update.
Great time to buy a lot of good news around the corner ...