Why don't you share with us your background and professional experience, then explain to us why we should rely on your scenario and disregard what I have learned from management and two highly qualified analyst's?
Ray, I can tell that you paid close attention to the conference call. You are the only one who has made intelligent comments since then. Wills said they would be down to 5 mil at the end of the trials, so everyone who has been bashing PTN will start blabbing about delisting. I think the chances are good that they will have received up to 7.5 mil from AZN. Assuming Phase 2b was successful, the nexat new cash should be coming from their new partner.
Seems like my $14.43 million estimate for the Phase 2B study was wrong (92.4% too high), considering that PTN is now saying they anticipate the cost for the study will be $7.5 million, with $2 million having been spent in the quarter ended 6/30/11.
PTN is saying they have $18.87 million in cash and equivalents as of 6/30/11 and that they intend to spend $5.5 million more on the Brem for FSD Phase 2B over the next 4 quarters, (lets say 6 quarters to 12/31/12) plus another $0.5 million on assorted research and about $1.3 million per quarter for 6 quarter, to which they add $0.2 million = $8 million for the six quarters (I forgot for what) and then they add another $1 million for ?"working capital"?.
And so they plan to be left with $3.87 million in cash and equivalents by 12/31/12.
(They actually said $4 million but they also started by rounding up their $18.87 million in cash to $19 million. So unless they know they will find $130,000 in the street over the next 6 months, I think $3.87 million is more accurate as of 12/31/2012.)
I like that they aren't counting on milestone payments from the obesity drug in their calculations because they certainly can't plan with that in mind.
I liked Mr. Wills' presentation in that he went the extra step to break things down and he seemed conservative (assuming the $7.5 million number is accurate).
He is reliably fact-based. You are reliably in la-la land. I'd say half-empty is optimistic here. Oh if only everyone was as clever as you. It must be lonely for you- hence your continued petulance.
But for the record, I seldom see any fact based posts from you outside of quoting Dr, M and the Lagos 9. Of course there are your Multi-basher sitings to deal with- Wait- There goes one now!!!
dont forget fil, that at the reception desk they replaced m&m's with jellybeans.
that should lead to substantial cost reduction savings, better the bottom line and stuff.
more dilutive financing coming, fools try to wish it away
u will c
did i rhyme?
Using this table, I multiply 400 patients by 36,070 per patient and I get ~$14.43 million.
This is an average and perhaps the Brem study is higher than average since it is being done entirely in the U.S. and Canada (the vast majority is in the U.S.) as opposed to being carried out in less developed countries where prices are cheaper.
But, just using the average, the total cost of the present Phase 2B study would be $14.43 million.
Dividing by 6 quarters, I think the Phase 2B study should increase quarterly costs by about $2.4 million for the last quarter or two and another four or five quarters.
So total operating expenses for these quarters might be around some portion of the previous $1.7 million for R&D plus $2.4 million in the study expense, so maybe $3.6 million for R&D?
Plus about $0.9 million for General and Administrative would give total operating expenses of about $4.5 million per quarter.
Phil, research was shut down awhile ago, right?
And I don't know when shareholder relations was cut but I'm guessing "shareholder relations" costs less than $200,000 per year.
R&D for the quarter ending 3/31/11 was 1.722 million and General and Administrative was already down to $0.956 million for the quarter down from about $1.28 million for the quarter in 2010.
I would guess the 400 patient study will cost about $10 million but I'm wild guessing.
If it takes 6 quarters to complete, I'm guessing we can roughly add $1.66 million per quarter to R&D?
The extra $1.66 million may not show up in the quarter ending 6/30/11
since they only recruited the first patient 6/28/11 but it should show up for the present quarter.
There is no free lunch. You can't have 31 out of 38 sites recruiting without paying for it.
So I'm off the cuff guessing operating expenses will be $4 million for this quarter and somewhere between $2.67 million and $4 million for the quarter ended 6/30/11.
So shall we predict that cash burn for the present quarter and the next 4 or 5 quarters should be about $4 million per quarter, minus whatever revenues accrue from the obesity and the asthma drug?
According to this site 31 out of 38 clinical sites are recruiting
So let's say 45 patients have been recruited so far, leaving 355 and let's say the other 7 sites start recruiting within a month and they all recruit 1.1 patients this next month (a generous number).
Then by 10/11/11 42 more patients will have been enrolled for a total of 87 with 313 patients left to be enrolled.
If they enroll 1.2 patients per month which is probably faster than they actually will enroll patients) that would be 45.6 per month and it would take 6.86 more months to enroll the last patient or until
I forgot about dropouts.
If only 3% drop out that would require the enrollment of 412 patients to get 400 patients completing the study, so I will add another 8 days and get that the last patient will be enrolled 5/15/2012.
Then add 20 weeks for the last patient to finish the study and we are up to Sept 29, 2012.
I'll move up my hoped-for completion date to sometime in December, 2012.
Thanks, yes, all good points.
So it seems like the number of clinical coordinators on site is the bottleneck and I guess you're saying that the CRO (Clinical Research Organization?)--the company that actually carries out the study--which on a quick read I did not see mentioned for this particular study
has other patients for other studies for these study coordinators to deal with.
Still to someone like me who doesn't see the work flow, I would imagine the clinical coordinator could take care of at least 1 patient per day in addition to his or her other duties.
So if the clinicians are referring 12 patients per month to the clinical coordinator, someone like me would think they could enroll the 6 per month that would be eligible for the study.
Then again, I'm obviously wrong with my imaginings because, as you point out, the fact is that only 1 or 2 get enrolled per month per site.
Ray- some other more granular issues to think about. Patients don't simply appear and start in the study. They need to be evaluated, undergo pre-screen interviews, physical exams, and screening blood work, receive informed consent, come back post-screen for their initiation interview and enrollment. So another metric is the screen/enrollment ratio - even if a site has many subjects the enrollment rate depends on how many subjects meet the inclusion and exclusion criteria, and to evaluate this we need to know specifically what those are.
Another factor at sites is how they go about supporting this work flow. How many nurses/ coordinators are devoted to the study? Usually no more than 1 or 2 at an academic site and at a CRO site they may be running several more competing studies.
So in the end it isn't just a matter of saying "we have lots of patients.". There are several variables at play. Not saying PTN can't do it mind you, but it is hard to see how one can say they will succeed at their tmelines without understanding the basics of running a trial.
IMO as always.
" So you don't think it's possible to recruit 400 patients from 32 sites in 8 months?"
Let's just start to play with Yanni's numbers of the usual pace being 1 patient per site per month and that another variable is how long it takes to get a lot of sites operational.
Just a quick foray, let's say they have 10 sites
open by now (I'm trying to be generous--I will take a look at http//www.clinicaltrials.gov later to see how many sites are listed as "recruiting") and let's say they have all recruited 1 patient per month.
That's 20 patients as of 9/11/11.
Let's say another 11 sites are opened per month and by 11/11/11 all 32 sites are open and they have continued to recruit 1 patient per month. That's another 21 + 32 = 53 patients for a total of 73 patients enrolled (327 remaining to be enrolled).
Let's say they enroll very fast at 1.5 patients per month per site or 48 patients per month.
Then they will have enrolled the last patient 6.8 months later or June 5, 2012.
20 weeks later they can get the last piece of data on the last patient.
That would be about 10/20/2012 until the last piece of data is gotten.
This sounds like a very optimistic scenario.
Using 1.2 patients per month per site (still optimistic) that is 38.6 patients per month from 11/11/11 or 8.5 months or 7/26/2012 and 20 weeks later they have the last piece of data on the last patient or 12/09/2012.
I expect the last data on the last patient will be an early 2013 event, January or February, 2013 is all I'm hoping for.