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Check out their power point presentation: (1/17):
http://c.eqcdn.com/_145f9f3f186607c6907567cb01941372/auriniapharma/db/246/890/pdf/January+Corporate+Presentation_AUPH_FINAL.pdf
Page 24:
"In previous studies, > 2000 patients have been treated with voclosporin with no abnormal or unexpected SAE’s—this remains the case upon review of the AURA data"
"13 deaths have been reported in the AURA study: pattern is consistent with other global Active LN studies1,2,3"
"11 of 13 deaths occurred at sites with compromised access to SoC; patients who died had a statistically different clinical baseline picture, demonstrating a more severe form of LN, potential comorbid conditions & poor nutrition"
"The Drug Safety Monitoring Board continues to meet on a regular basis & provides recommendations on study protocol/conduct. The AURA study remains ONGOING to its 48 week secondary endpoints"
(i.e., if DSMB thought there were any deaths directly due to the Voclosporin, safety monitoring board would have halted the trial with a clinical hold).
-----------------
SAE and Mortality comparisons of Voclosporin Phase 2b with other LN studies on Page 25
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Planned Voclosporin Phase 3 appears to have favorable endpoints compared to Phase 2b (Pages 30-31).
Hey, kei:
Here are highlights from the 10/14/16 PR on the financing:
- Agreement with 2 investors, 8.5M shares at $1.3425 to raise about $11.4 million in gross proceeds.
- 4.25M warrants at exercise price of $1.45
- “...will greatly strengthen 22nd Century’s balance sheet and will ensure that the Company has more than 18 months of operating cash on hand,” explained Henry Sicignano, III, President and CEO of 22nd Century Group.
- “22nd Century looks forward to several important R&D catalysts in the coming months; this capital infusion will significantly improve our negotiating position in discussions with potential strategic partners.”
- Chardan Capital Markets, LLC acted as the sole placement agent for this transaction. (not surprising)
Rip van Winkle
Sounds like the 3:30 (?) presentation today was a hit, in the midst of the market collapse. I haven't listened to it yet, but I hope to over the weekend...
One other point about option grants...if exercised, these options raises money for the company at the exercise price.
Granting of options is standard operating procedure for small development-stage biotechs.
Extending of options is SOP for small, development-stage biotechs.
There is nothing unusual in what IPCI is doing.
------------------------------------------
These recent grant of options is great news...what company would grant options to their principals if they expect the share price to go down, right???
If IPCI doubles in share price over the next year, what shareholder would be upset about these option grants?
But, the shorts should be a bit concerned...
Longs can expect positive news flows...
More option grants. Getting ready to rock and roll.
Della Penna 70,000 @ C$2.42
Odidi,Amina 90,000 @ C$2.42
Odidi, Isa 90,000 @ C$2.42
Yat,Patrick 25,000 @ C$2.42
Interface to Canadian SEDI database:
https://www.sedi.ca/sedi/SVTItdController?locale=en_CA
Option grants exercise price work out to about US$1.85/share, at current exchange rates.
I think the price on option grants are determined by the previous 10 day average share price, but I"m not sure on this.
Samsa:
These are GRANT of options, not exercise of options?
As far as I know, options can be granted at any time, without fear of SEC action.
Grant of options filed today:
Akyempon, Christian (senior officer): 15,000 shs (exercise price @ C$2.42)
Madhani, Bahadur (director): 35,000 shs (ex pr @ C$2.42)
Smith, Eldon (director): 35,000 shs (ex pr @ C$2.42)
Could mean we are close to NDA filing
Wimusky:
What is your source that manufacturer's name isn't required for NDA?
Wimusky:
Will do Monday morning.
Wimusky:
I agree that they don't need a partner to file the NDA.
But I believe they DO need a manufacturer.
My best guess is that the NDA is all set to go, except revealing the name of the contract manufacturer or partner/manufacturer.
My read of the 505(b)(2) NDA is that a manufacturer name/address must be explicitly stated in the NDA.
Therefore, I think IPCI is reviewing proposals for a contract manufacturer verses a full partner (marketing and manufacturing), trying to decide the best path forward for shareholders.
If you look at ELTP, who also filed a 505(b)(2) NDA, they had a contract manufacturing agreement before filing their NDA.
I think (hope) we're close.
Intellipharmaceutics to Present at the 18 th Annual Rodman & Renshaw Global Investment Conference
TORONTO, August 25, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the Company is scheduled to present at the 18 th Annual Rodman & Renshaw Global Investment Conference on September 13, 2016. Domenic Della Penna, Chief Financial Officer, will be presenting at 2:10 P.M. (Eastern Time) in the Lotte New York Palace Hotel in New York City.
If you are an institutional investor, and would like to attend the Company’s presentation or arrange a one on one meeting with the Company, please click on the following link (www.rodmanevents.com) to register for the conference.
The presentation may be accessed through the Investor Relations' Events and Presentations section on Intellipharmaceutics' website at www.intellipharmaceutics.com.
The Company has provided a full valuation allowance on the Company’s loss carry-forwards as it is more likely than not that its loss carry-forwards will not be realized.
I think you need to be a CPA to understand this, lol. I don't really understand it, but this document might be useful:
http://accounting-financial-tax.com/2009/08/deferred-tax-asset-and-its-valuation-allowance-with-case-examples/
It appears that for carry-forward tax losses, a company has to assess likelihood of realizing this carry-forward (more likely than not or less likely than not), in order to determine how to handle this carry-forward in this tax year and future tax years.
To assess the likelihood of realizing, CFO needs to look at recent few years of performance (profit or loss?) and the near-term projection of profitability (this year & next year). If we (IPCI) had a signed contract with a pharmaceutical OR we had an FDA approval, my best guess is this statement would be changed to "more likely than not that its loss carry-forwards WILL be realized. But, I'm not a CPA.
I can't see how it would be different for 505(b)(2).
I expect to see a news release around the time of the NDA application, stating that they've hired a US contract manufacturer OR a partnership with a company with US manufacturing capability.
I suppose they could use a CTO (confidential treatment order), if for some reason they didn't want to release the name of the manufacturer or partner or the details of the arrangement.
In any case, should be soon.
I wonder if IPCI and/or the partner were waiting to see the fate of ELTP and their PDUFA a few weeks back? That will have a direct impact (positive) on market potential if Rexista is approved.
This is the document where I saw the name/address of manufacturer is required:
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM182538.pdf
Page 8. Again, it's not clear if this is for 505(b)(2) as well as 505(b)(1).
FDA advisory committee backs Egalet's long-acting abuse-deterrent morphine, 18-1. Not sure when their PDUFA date is.
http://finance.yahoo.com/news/u-panel-backs-approval-egalets-202905254.html
Samsa: IPCI could either sign a contract with a partner that has manufacturing capability OR hire a contract manufacturer.
From my research, it's probable that the name/address of the manufacturer needs to be named in our NDA at the time of submission. I believe the manufacturer has to be named in the 505(b)(1) NDA submission, so more than likely the manufacturer has to be named in our NDA (505(b)(2)) application as well.
Yes, CMC (Chemistry, Manufacturing, and Controls) section is required for an NDA submission. However, the manufacturing site inspection by the FDA is separate from the NDA.
I learned from IR today that the Canadian facility can't be used as our manufacturing site, since schedule 2 drugs can't be imported to the US.
Wimusky:
Excellent suggestion, and I just did.
Rexista is a schedule 2 drug, and as such can't be imported into the US.
Options are still open as to whether they will partner with a company with US manufacturing capability or contract manufacture in the US.
Regards
Mike:
That is good news. I would assume expansion would require a re-certification, but I don't know how long this process would take (6+ months?).
With so little news on the manufacturing/marketing front, I do start to wonder about accepting a buyout (Teva? Purdue?), but that wouldn't likely happen until FDA approval.
For comparison, ELTP signed a marketing agreement over a year ago for ELT-200 (which recently received a CRL from the FDA).
ELTP also signed a contract manufacturing agreement over 3 years ago, but that agreement included up to 12 generic products.
I believe the current uncertainty comes down to 2 things: manufacturing and sales teams. Until there is clarity on the direction the company takes on both of these issues, either through partnership or raising capital, many institutional investors will feel there is too much uncertainty for investment. At this time, large investors are waiting to see if Odidi and Della Penna can execute the buildup for rollout of Rexista.
Manufacturing: IPCI can manufacture in-house OR sign a contract manufacturing agreement OR partner. Manufacturing in-house will cost on the order of $5M-15M, depending on building purchase/rental and the scale of manufacturing. Even more important, if they do in-house manufacturing, they need to do the build-out and then get FDA approval of the manufacture sight as CGMP (current good manufacturing practice), which will likely take 12-18 months if they start now! In my mind, it's too late to do the manufacturing on their own, so they either have to do contract manufacturing or get a partner. In that they haven't announced a contract manufacturer at this stage of the game, a partner with CGMP-approved manufacturing capability is the most likely scenario.
Marketing: again, either in-house OR sign a contract marketing/sales agreement OR they need a partner. I don't see any signs of hiring a sales team which, once fully staffed, will likely cost $1.5-3M/quarter. Too much of a burden for IPCI at this stage. Contract sales is a possibility, but again, I think a partnership is the most likely scenario.
If we are waiting on a partnership, why isn't it signed yet? Clearly, they can't agree on terms (upfront payment, royalty, milestones). My best guess is that a potential partner is waiting for more certainty before meeting IPCI's negotiation demands. Just finishing the filing (due any day now) only gives a little reassurance to a partner, so the partner may be looking for acceptance of the filing by the FDA (the 74-day letter). But, one thing is clear: Manufacturing/sales teams must be put in place within the next few months, or the rollout of Rexista (hopefully in February) will be delayed.
One thing that may be holding up a partnership: TEVA (a potential partner) has just completed a $40B acquisition of the generic business of Actavis. Until the merger of this business unit is complete, TEVA management might have a moratorium on any new partnerships.
My costs and timelines for manufacturing/sales teams are just estimates. I welcome any corrections.
Wow, almost exactly 1 year to the day since the Focalin/FDA debacle.
Seems like we should be hearing something from the FDA soon, but I've been thinking that for about 4 months, lol.
GREAT question, Angelo!
This was one of my questions, as well.
Thanks for asking and sharing CFO's response.
I listened to the ELTP call.
As best I can tell (the accent of the CEO was a bit thick at times), they do testing with various foods to verify onset of the active drug is the same as the original (Oxycodone XR).
From what I was able to pick up, there was a delay in the onset of the active drug when tested with fatty foods.
As described by the CEO, the FDA was concerned about this delay with fatty foods, because they thought that a patient might decide to take another dose of Oxycodone, since the effect of the original dose wasn't kicking in.
In order for the label to say "with food or without food", it has to have consistent onset of the effects of the drug.
The ELTP CEO sounded really ticked, as he felt that the FDA should have flagged this in their early discussions as an issue.
If anyone else heard differently, feel free to correct me.
This website gives simple clarity on each review cycle:
http://www.biotechduediligence.com/blog/fda-pdufa-v-review-timelines-for-ndas-and-blas
NME (new molecular entity) would be 505(b)(1) (e.g. Veltassa/Relypsa)
non-NME would be 505(b)(2) (e.g. Elite's drug or Rexista)
So, this explains why Veltassa/Relypsa, my first example, had a 60 days to accept NDA + 10 month review (NME, standard review).
This also explains why Elite, my second example, had a review 6 months after NDA was submitted (non-NME, priority review).
If Rexista has priority review (I can't see any reason why it wouldn't), it should have the same review cycle as Elite Pharma. Like you, I'm expecting Rexista PDUFA date will be some time in February, assuming NDA is filed some time in August and NDA is accepted by the FDA in October.
Thanks for pointing out ELTP, Crimson! I did not realize that a 4-month review is possible for a 505(b)(2) NDA.
I'm definitely hoping for February!
I definitely expect a bump in share price after the NDA filing, but who knows if it will retrace?
The more important milestones, to me:
- Acceptance by FDA of the NDA (within 2 months of filing, as they have to do a summary review to make sure NDA is in order). This is a major milestone, because an RTF letter from the FDA would be a significant setback in time.
- Partnership. Either they will have to partner or sell shares by the end of the year to get ready for launch. I'm confident they realize doing their own manufacturing and sales is far too dilutive to attempt at current prices, so I expect a partnership before the PDUFA date. Terms would be better if they wait for approval (Q1 '17?), but IMO signing a partnership before approval is much less risky.
- Approval.
Great news for IPCI! We could get to market before ELTP...less competition!
Looking at the timelines for ELTP news releases:
- Jan. 13, 2016 -- Elite submitted 505(b)(2) NDA for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone.
- March 17, 2016 -- Elite announced NDA for SequestOXTM (ELI-200) has been accepted and granted priority review by the FDA. The FDA has set a target action date under the PDUFA of July 14, 2016.
- July 15, 2016 -- Elite announced that the FDA has issued a Complete Response Letter (the "CRL") regarding the NDA for SequestOx™.
What I find interesting here is that the review time was targeted at 4 months for a priority review by the FDA after the NDA was accepted. Perhaps this is because the Elite NDA was a 505(b)(2) review? A 505(b)(2) relies on a previously approved product that was submitted with a standard NDA. That is, the FDA doesn't have to review new clinical trials and biochemistry of Oxycodone, just the bioequivalence studies conducted by IPCI. Much less work for the FDA to review.
The good news is that Rexista will be filed under the same 505(b)(2) pathway, so if we get a priority review, we may get the same 4 month review cycle! This would put the PDUFA date at approximately February 1 (not the April 1 I mentioned in my previous post).
Questions for IPCI management: do we expect a priority review after the NDA is accepted? Will this be a 4-month review?
I, too, wish they would act more quickly, but I don't expect they will. Cancer drugs for dying patients can expect their review to require the full allotted time, which is why the priority designation is so important. This cuts the review cycle time from 12 months to 8 months.
NDA paperwork can be thousands of pages of documents, and require review by several individuals in different disciplines (biochemistry, statistics, manufacturing, etc).
As an aside, getting a refuse-to-file (RTF) letter resets the clock, causing many month delays. An RTF requires the applicant to:
(1) schedule a meeting with the FDA to discuss the items in the NDA that are incomplete or need to be resolved (2+ months)
(2) edit and resubmit the NDA (2+ months)
(3) wait 2 months for the acceptance of the NDA.
This resubmission process takes > 6 months, assuming there are no new trials that the FDA recommends.
Therefore, it is critical that IPCI gets it right on the NDA submission the first time. I'd rather they have a month or two delay in order to get the NDA right the first time than to wait the 6+ months for a resubmission! Patience...
The PDUFA legislation mandated that the FDA must respond to an NDA within 60 days. Before PDUFA, there was a backlog of NDAs at times that caused long delays (> 60 days) of NDA acceptance (sound familiar??).
The FDA usually takes close to the full 60 days to accept/reject the NDA.
As an example, Relypsa recently went through an NDA for Veltassa:
- October 22, 2014: Submitted NDA
- December 15, 2014: NDA accepted by the FDA
- January 5, 2015: ("day-74 letter") Assigned a PDUFA date of October 21, 2015 and FDA "further indicated that it does not currently plan to convene an Advisory Committee for advice on the company's NDA.". This was a standard 10-month review.
- October 21, 2015: FDA approves Veltassa
Schedule for Rexista will go something like this:
- August 1, 2016: NDA filed by company (just a guess on the date)
- October 1, 2016: FDA Accepts NDA or issues Refuse-To-File (RTF) letter within 60 days of NDA filing.
- April 1, 2017: If NDA accepted, PDUFA (decision) date is set for 6 months later if Rexista is priority review--I think Rexista is priority review? (10 months later if Rexista is standard review)
- ~March 1, 2017: If FDA needs guidance on the NDA, they will set a date for an Advisory Committee (AdCom) 2-4 weeks before the PDUFA date, and publicly release Briefing Docs (BDs) ~3-5 days before the AdCom.
NDA = New Drug Application
PDUFA = Prescription Drug User Fee Act
I'm very impressed. We could have been totally screwed on this financing by a shady investment banker. On these types of transactions, I've commonly seen a 10% haircut off the closing price on the common shares sold (i.e. 1.40s instead of 1.61), with full warrants attached instead of the half warrants negotiated at 1.93. Also, the trading halt to allow the financing to complete and the market to digest was very professional.
Well done by Della Penna, Dawson James and management to arrange and close this deal. It shows that there is strong belief in the assets of this company.
Sad that the FDA is so messed up on ANDA reviews that it had to come to a financing at this low price.
I added again (hopefully my last add!) in the 1.50s.
Same here, dtstx. I've been adding at these levels, as well.
Long shares still the way to go with the MAJORITY of anyone's money at these prices.
And yes, there is always selling call options as a way to hedge or make extra money on the side.
But, if s/he sells $2.50 October calls, s/he is capping his/her gains, as those shares will surely get called away long before the stock hits $5.50.
Screen shots of his share and option activity would solve Sport's credibility issue here!