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Yes, data lock or database freeze is a required step. How quickly analysis and result follow depends so much on the trial size and resources used .. but what I have seen for reporting top line (PASI 75 scores only) from 200 subject trial one week would be on the side of exceptionally fast, 2 to 4 weeks about normal and even 6 weeks would not be that abnormal. ffrol or KarinCA might disagree. If they do, adopt their numbers. I am fairly certain that they (at least) have longer experience than me in observing these things.
That is good to know. Learning every day. Thanks.
ffrol,
we don't have full text for the Purchase Agreement. There are omissions in the public version including 2 under PURCHASE OF COMMON STOCK and one under EVENTS OF DEFAULT.
We cannot say that we definitely know that the sale was not permitted under the Agreement because we don't know what is in the complete agreement. And I would hazard a guess that it is fruitless to go asking what might be in those omitted sections.
ffrol, two observations.
1. According to May 10, 2017 IPIX press release prurisol interim results were planned at 6 weeks of treatment, presumably with full ITT for the report to make any sense. How the enrollment was going that condition was not met before mid Oct 2017.
2. According to IPIX quarterly reports from 2016-Q3 to 2017-Q2 IPIX was conducting its trial(s) without any overall contract(s) with CRO(s) until Q2 2017 when they entered into contract with minimum anticipated commitment of $6M. Prurisol trial was probably at about 50 % of full enrollment at the end of Q1 2017 and 70 % of target enrollment was reached in May 2017.
Some comments:
A. At 6 weeks pruisols data would have been a poor predictor for final outcome. Useless report.
B. One wonders why the change in the contracting approach in the middle of the biggest trial they had had so far? And how much else did change with the contract? And what were the implications of these possible changes for trial and reporting schedules?
The reason for the big contract could be as simple as IPIX trying to control costs with fixed contract or CRO demanding it. But it also could be IPIX trying to prevent the trial becoming a bigger mess that it already was. If so, the subsequent non-material non-events and delays seem to fit quite well. And communicating about them would have been an embarrassment they rather avoided.
But the above is living in the past. Leo's email seem to indicate and the things with prurisol are finally getting in order. We will see, and soon. I hope.
LR - You are right as usual. When I condensed my big table I deleted a wrong column. Sorry, should have been for clinical studies.
2017-Q1 [1],[2] - $2.1M
2017-Q2 [3] - $3.4M
2017-Q3 - $2.8M
2017-Q4 - $2.3M
2018-Q1 - $1.8M
Can't really blame my mild dyslexia for that. However, the question still remains: Why it looks like somebody got caught with his pants down at IPIX? Your CRO payment is one of the few possibilities I consider reasonable. Especially if CRO ended reprocessing what IPIX had done in-house. Good Luck. And Thanks.
LT, it might do some good if you took a fresh look at that page 24. I am NOT USING numbers for R&D as a whole, ONLY FOR NON-PAYROLL CLINICAL R&D - as on the first line of the breakdown of R&D costs on page 24. I thought it is not much use to compare payroll numbers if I am looking for external payments. Might have been a mistake, Huh?
Maybe I stumbled onto ... something. I decided to take another look if there is anything in IPIX financial reports that might shed some light on how IPIX ended up resorting to "exceptional financing". Below is condensed table of my latest effort.
Notes:
[1] Reported as cost of clinical studies and development research. Excludes R&D related payroll, stock-based compensation and depreciation and amortization of IP.
[2] Excludes related party debt, which stayed nearly unchanged at about $1.5 million from 2017-Q1 to 2018-Q1
[3] The company had no contractual minimum commitments to Contract Research Organizations as of March 31, 2017.
[4] Quarterly Sale of Shares calculated as difference between reported sales for 9 months up to Mar 31, 2017 and 6 months up to Dec 31, 2016.
[5] Clinical Studies and Sale of Shares calculated as difference between reported values in 2017 10-K and the values reported in 3 previous 10-Q:s
Note 3 is interesting. No CRO under contract on March 31, 2017. Prurisol trial was already recruiting and would hit 70 % of target population in the following May. Did IPIX contract and pay CRO(s) per achievement or work unit (why then $6M commitment during the following Q) or did IPIX start prurisol trial with (mostly) in-house resources and handed the trial over CRO in mid-stream, so to speak. The latter choice is a sure fire way of getting into schedule killing hot mess. I can vouch for that from very unpleasant experiences (I guess kfcyahoo can provide heavy support). Maybe IPIX management realized being far over their corporate heads with no other choice than going for CROws.
Otherwise, I am at my wits end with why IPIX quite obviously (look at cash, sales of shares) was not prepared for what was coming.
I don't think it is a question of foresight but being blindsided by something not necessarily unpleasant or unwelcome but in any case costly. What? Leo knows but is not telling.
ffrol, you are getting darker day by day. Why my brother? I think Leo's response to you means that he knows that satisfactory resolution is near (oh my, I sound like revival preacher - had to change wording from good to satisfactory in order to sound less biblical).
kfcyahoo,
"Budget and schedule are combed over monthly, at least, and reviewed with all supervisors and company execs." I think we are arguing in the same direction: Leo should have seen what was coming or not coming. He didn't build any buffer and was forced to improvise to the tune of $2M. Begs to question what was so unpredictable.
Or using Leo's terms. Why the cost of Brilacidin production was not visible in January or February 2018. Or clinical trial costs for trial X (X can take values P or ?)?
ffrol,
1. My mistake. should have been 0.70 both.
2. I get the savings moves. But those don't explain why not sell few million more shares to future proof their bank account a little bit when there was obvious volume and price room to do so. Especially if they did not have any guarantee of getting fat wallets aboard by Q2 or Q3 2018.
Did Aspire balk at some time in February? - that would have a breach of contract according to how I read the Agreement (not my strong point, as amply demonstrated).
kfcyahoo, I keep forgetting to compliment you about CPM quip. Got a good chuckle out me. But, you can't be implying that Leo did not anticipate salary and bonus costs. I think that whatever caused the 'exceptional' $2M financing sale was an unanticipated and unplanned for event. And I have hard time of accepting Leo & Co being so daft that they would not prepare (in time) for possible deal delay or fall thru.
SS, I suspect that we both know the answer: Leo has always raised enough to meet the anticipated costs for next one or two quarters and no more. That has worked fine, until this spring.
I have a little problem with IPIX share sales pattern
Above are share sales volumes and proceeds as stated in the 2 latest IPIX 10-Q plus share volume and price info from Yahoo finance. Some observations
1. The drop in share volume from 2017-Q4 to 2018-Q1 can be attributed almost completely to decline in Aspire sales.
2. Somehow Aspire managed to sell nearly 7 million shares with nary a drop in share price during 2017-Q4 (Yes, probably prevented price going up, but that is not the point here)
But those are not what I have a problem with. THIS IS:
Do you see any evidence in share sales that
1. IPIX was preparing for going alone with B. Or even for possibility of that happening as one would expect even from semi-clueless management?
2. IPIX anticipated any sort spending increase in the near future, like in the next quarter, during 2018-Q1?
To me it seems that IPIX could have easily sold at least 2 to 3 million additional shares for one cool $ million or so during the early part of Q1 without pushing the share price drastically down. As evidenced by share price being at $ 0.73 at the end of january with monthly volume over 5 million shares. Price decline started in February as did volume drop to 3 to 4 million level. Well, they didn't. And that mystifies me.
What am I missing, again?
Most if not all questionnaires are either multiple choice or the patient assigns a single digit numerical values for severity of symptoms like itch. I have no clue what kind of consistency checks CRO might apply on questionnaire data but there must be some.
Thanks. Excellent points. I guess you are also saying I should keep my mouth shut about accounting issues. I try to oblige.
Could be. But then why the hurry and probable delay of P results in order to get one hand's on B. It is not that they have funding for any sort phase 3 trial available with current agreement via Aspire. Leo might end up sitting on a blob of wasted B (no S).
Your bias - your opinion. We'll see.
I didn't mean it that way. Maybe somebody wants IPIX to do a small confirmatory trial with B (hence production) and the deal is subject to the results of that study. Would not be the first time.
Otherwise the situation would be that IPIX is prioritizing B production for future trials without or with a partner over the results from P trial. To me that is very much the same as IPIX giving up on P. I am not willing to go there yet. We'll see.
SS, a bit biased musing, don't you think? More balanced would have been
"Unless of course, you had a good idea about results... or you needed Brilacidin in a hurry."
In any case: well done F. You got thru. I can go and do some pruning now - will be safer to trees than would have been yesterday. Well done!!!!!
"They're manufacturing B in preparation for the next clinical trial."
... sort of. My guess: the urgency to get Brilacidin maybe due to a conditional B deal in the works - subject to some confirmatory studies by IPIX. Who knows. Otherwise I agree. More on the side of good news than bad.
$1M should have been in my previous post just after minimum:
"At the end of Q1 2018 IPIX had minimum $1M financial commitment to CRO". Me daft person.
ffrol, you are probably right about issues with prurisol originating from CRO side. What scant evidence we have points to that direction:
At the end of Q1 2018 IPIX had minimum financial commitment to CRO and "Expenses are recognized when services are performed by the contract research organizations". Either CRO had work still to be done or was waiting to be paid for work recently finished. In either case $1M is a lot of payable hours. Pointing the finger to CRO does not take IPIX off the hook. I suspect IPIX may have initiated this mess by putting pressure on CRO. And we have the classical too many cooks ...
IPIX Financial Obligations to CRO
2017-Q2 -- Commitment: $6.0M
2017-Q3 -- Commitment: $4.0M -- Quarterly Burn: $2.0M
2017-Q4 -- Commitment: $2.7M -- Quarterly Burn: $1.3M
2018-Q1 -- Commitment: $1.0M -- Quarterly Burn: $1.7M
Considering that 2017-Q3 burn rate probably has some residuals for the work with Brilacidin the above would make the average monthly cost for prurisol related CRO services to be about $0.5M. That would translate at the end of Q1 2018 to about 2 months of additional work. Feel free to disagree.
Thanks ffrol. I guess my DD skill needs some improving. Yes, I have sent few emails to Leo about P results - silence. But then, I am not reputable investor :)
I hope you are correct about B negotiation whatever the schedule.
About K: it may be off hold sooner than some people think. Aprea's ovarian cancer studies have primary completion dates Sep-2018 and Nov-2018. If Aprea succeeds with APR-246 then one well designed P1/2 trial showing that Kevetrin does indeed activate p53 in human should generate plenty of mee-too interest.
CDAs out for years? What are you talking about, ffrol?????
I assumed that CDAs came into being during Q4 2017 and negotiation phase probably started early January 2018. Others, with experience I don't have, keep saying that typical time spent in license negotiations (after CDA) is no less than 6 months and usually no more than 12 months.
I can't say how odd it might be in tiny biotech (never worked in tiny biotech), but, from experience, it is not so odd in tiny tech. I was once simultaneously a chief technology officer in a legal arbitration firm, a chief science officer in a pharma laboratory software development firm and a lead developer in a third which did the actual heavy lifting under contract to other two. All tiny startups, and worth leaving as soon as possible except the layers who paid well, so I stayed in contact. Totally different field(s) from biotech, I know.
I take regulatory officer meaning a person responsible for regulatory (FDA) contacts and company's adherence to GxP. NanoV was pre-clinical stage company running mostly non-GLP stuff during Menon's time - there probably was few, if any contacts to FDA. What was Menon doing there? Sleeping?
Aaargh. So Sorreee, SS. TOTALLY MY COW DROPPINGS. Menon seems to have resigned officially 2014 but may have lingered on some time longer as an 'unpaid' consultant. At least I have a recollection of NanoV using the word unpaid in describing the co's relationship to Menon in a later (probably) SEC filing, but I can't find the freaking doc now!
I agree about prurisol. As to Brilacidin deal my anticipation has always been:
not likely during Q2 - likeliest during Q3, hope waning during Q4 and probably no deal if time count goes to 2019. It depends on over what and with whom IPIX is negotiating. Bigger the company, slower the process - and the same applies to the scope of the deal.
In Re: Nanoviricides - Resignation of Leo Ehrlich
Dear Fast Draw SS. Are you sure you don't want to correct your statement. It's more than misleading.
See:https://www.sec.gov/Archives/edgar/data/1379006/000114036107010671/form8k.htm
If you are referring to my latest graph you so are badly off that you are not even wrong. I have to assume you don't understand. The graph is not based on IPIX trial but to about 15000 psoriasis subjects, including 6 arms with less than 30 subjects, 19 with less than 50 subjects etc. Jeez, TIAB the eminent clinical statistician, stop and think for once before wailing.
Here is a statement for you to chew:
In 199 psoriasis trial arms encompassing about 46000 subjects and including 18 arms with less than 30 subjects, 56 arms less than 50 subjects and 91 arms with less than 100 subject the highest reported sPGA 0 response with placebo is 1.8 % with standard deviation of 0.5 %. This makes me concluded that sPGA 0 response rate of 10.7 % reported for 200 mg arm in prurisol phase 2a trial is not a fluke attributable to placebo response because it presents more than 6 sigma deviation from the historical norm for the said response. A level of deviation that is considered a proof even in particle physics or cosmology. Furthermore, the graph in my previous post shows that the ratio of reported sPGA 0/1 and sPGA 0 responses for 200 mg dose in prurisol phase 2a trial is consistent with historical data.
As to what my graph says about response for 400 mg dose ... or when, if ever, we will see prurisol p2b results.. well, those I leave to others.
George, it would be frivolous to do least squares fit on 3 real data points. But ...
Don't worry. I am not going to leave you empty handed. Below is historical PASI 75 response against sPGA 0 response for 65 psoriasis trial arms for which both responses have been reported.
You might remember me saying that prurisol phase 2b had sPGA 0 response of 10.7 % for 200 mg arm. That means 3 subjects out of 28 and at least 2 out of 3 in the baseline sPGA 3 group (19 subjects). That is hard to explain as a fluke against the observation that the largest historical sPGA 0 response for placebo so far is 1.8 %.
For the chart above I assumed that probable response range for scaled up trial would correspond to 2 to 4 sPGA 0 responses in prurisol 2a trial. That is the green area in the plot.
You are free to speculate along the lines: If about 10 % sPGA 0 response historically implies PASI 75 response in the range 30 to 60 %, then what might doubling that sPGA 0 response imply for PASI 75 response?
Good luck.
LR, Thanks for posting your considerations - as usual I learned a lot. About treatment of serious adverse events during clinical trials. This is my understanding as succinctly as possible (pardon the convoluted language)
IND Safety Report:
1. Any suspected treatment emergent uncommon serious adverse event or
2. Aggregate of suspected treatment emergent serious adverse events occurring more frequently with treatment than in a concurrent or historical control group
must be reported to FDA and other investigational sites as soon as possible but no later than 15 days after determination. Immediately life threatening serious adverse events (category 4) and deaths due adverse events must be reported within 7 days.
How and when this could turn into a material and reportable event under SEC rules? Probably when FDA or sponsor takes an action based on IND safety reports. Halting or terminating a trial would qualify. I don't know if any trial protocol change would, probably not. Otherwise it is business as usual.
Dougwur, I use my cost basis as the base for the bagger i.e. 10 bagger means: get your investment back ten fold minus pesky taxes. In the case of IPIX my 10 bagger would be SP ~ $7.2 because IPIX has generously allowed me to bring my cost basis down. I am fairly certain that it was not their intention.
Leo's problem is that he does not have any progress to communicate.
Scenario A:
1. He can't really say anything about ongoing negotiations and that may include even saying that there are ongoing negotiations. Some enterprising law firm might later sue him for misleading public if the deal falls thru: "We will show that IPIX knew, or at least had notable reasons to believe already on ... that the deal would not be consummated."
2. Nothing worth reporting has happened on other fronts like prurisol trial. Somebody messed up, and re-process is ongoing. I am not certain that Leo knows who, how and when. Even if he knows something about the delay it might be better for IPIX not to pick up a public fight with CRO before the results are in.
Scenario B:
1. There are no negotiations. Interest dried up after suitors took a gander at data. We are left to figure this one out as time goes by.
2. IPIX and it's CROw are furiously figuring out how to put lipstick on a pig formerly known as prurisol trial phase 2b.
ffrol has made some good inferences in support of scenario A. I am with him. BTW, I may have forgotten to welcome you in the world of biopharma investing. After few forays in you stop minding the cases when you burned your ass. Oh, I am lying, it just will hurt less because all scar tissue that is already there. And a 10 bagger is better painkiller than any opioid.
Okay. Not fighting your logic. A question though: does this mean that you think Aspire is done or near done with selling the 8M batch?
Well, if you take a really generous look at B maybe you can say that next phase in ABSSSI would be phase 3 because of large past ABSSSI trials. Never mind that the next trial will probably be p1 or p2 in anything but ABSSSI.
You have encountered a prime example of pharma's eternally optimistic forward looking clinical parlance: If a drug clears phase X trial in indication Y it is instantly promoted to be known as phase X+1 drug (no mention of indication Y unless really, really necessary like when presenting in front of serious investors). Looks so much better in general purpose press releases when you omit that "in Y indication".
Not really a joke. I am more than half serious.
Yes, 4M is admittedly a guess. Total share volume between now and April 1st is about 11M. I just don't see how Aspire could have squeezed in 8M shares without bringing SP below $ 0.30. I am comfortable of Aspire managing 30 to 40 % of the volume. But that may be my deficient thinking, in which case I do apologize.
Obviously you have a point, I am not denying it. I was only saying that Karin meant that Dr. Reddy is no longer the contract manufacturer for IPIX, Evonik is. Nothing more. A good thing considering Dr. Reddy's problems with FDA, I presume. What happens with Evonik is still a big IF, nothing more.
I don't think so, but discerning volume patterns is not my talent. To me things look like Aspire has been off market since mid-May, unless they are doing a really artful trickle selling. Weird, they are likely sitting on 4M plus shares. You and LR probably think that the unsold count is less, maybe you are right. But whatever the number is it is substantial compared to average daily volume.