NICE POST Dewophile- with regards to your post and Nerfs question-

I think the 25/50 dose is for two reasons: one is inverse relationship stated by dewophile and two is because there needs to be consistency with chronic fibroids and endo trials which are more efficacious at those doses and have an inverse relationship and need to build a safety database.

Dewo- care to discuss what fund that was?
I think all the funds I know who have done a lot of work love the drug.

JP is going on a roadshow in the coming weeks- I will ask for additional q's from the board in prep for that meeting.

Ymaxx you seem like a reasonable guy but to try to draw a link between Efficacy and the shorts is just silly.


What concerns me is the sheer number of healthcare funds or funds exposed to healthcare with fund of fund money which is fickle and being pulled, forcing selling in the sector.

Why is Dew so hot and heavy over GTCB. I had a 1:1 with those guys when they came through on a roadshow to see funds in my city and was less than impressed. I agree there has been serial dilution with those clowns. Frankly given his investment track record, I am reassured by his low 36% chance of success for anemia- he's proven himself a contrarian indicator in perpetuity as far as I am concerned.

Charmed, i think a little patience is called for. It has only been a couple of months since mgmt has been willing to license the drug. The consistent message to the scientific/pharma community prior to that point was one of "we are going it alone and intend to sell the company at point xyz". We all know partnerships take months to solicit, negotiate, finalize, etc.

I'm glad you showed up finally after all your doom and gloom pre-IND effective postings.
i) they got the dosing they want
ii) they got the timeframe they want
iii) the bar is 1/2 what was seen in prior studies (where the effect was retroactively studied)
iv) similar patient number as seen with prior studies

FDA seems on board to me.

b/c the 50 has shown the most efficacy across the prior trials and the FDA wants consistency with 25 and 50mg.

Well Lupron is used pre-op for that indication AND we have all seen how efficacy of Proellex is better than (in some studies) and at worst equal to (in others not reaching p<.05 vs Lupron) Lupron in previous studies.

I would agree with you in that I also believe that at the inception of the fibroid trial design it probably was not assumed that Hgb would "normalize" as a result of tx. I understand everyone's aversion to "data mining", especially when it comes to patient groups- e.g. only take patients with this characteristic or this value. However, I liken this situation to noticing that Avastin works on this cancer, that cancer and macular degeneration. They are simply arguing that stopping bleeding, a symptom of fibroids (in addition to "bulkiness", etc.), will also help raise hemoglobin. I know a lot about hemostatsis from med school and that's a very basic assumption.

If your email(s) havent been replied to i would leave him a msg.

The below sounds as well crafted as Joe/Wayne's questions on the last RPRX conference call.

i) Stat sig was hit using a bar that was over 2x higher on fewer patients. When has having these two drug arms hurt RPRX before- pls see their prior efficacy results.

ii) If they made the patient numbers higher (they dont have to b/c of the strong efficacy signal), you would complain they are taking too much time for the trials so they chose the lesser of the two evils.

iii) They respond to emails. who have you emailed? Have you called them so many times that they are hiding from your emails? Just kidding.

If you are concerned with trial size being too small b/c there is such a large efficacy signal, that's like walking into a bar in Aruba with Joran and him passing you a drink and you being concerned about second hand smoke. If a high efficacy signal concerns you, let alone (lack of) efficacy from most biotech drugs out there, you should probably just avoid the sector in general- it's too risky for you.








--------------"A few of questions regarding the anemia IND:

1) The numbers per arm seem a little small, though they are larger than in P2. Bad luck in placebo response or iron deficiency in drug arms could muck things up. Having two drug arms seems a little risky, too.

which leads to

2) Anybody think the patient numbers ought to be higher or that management might be open to that? Is 85% power enough?

which leads to

3) I see IR doesn't respond to emails, only calls. Has anyone here tried this? Are they responsive?

Edit: Oops, forgot one . . . Was this subset prospectively defined in P2, that is not data mined?

TIA & Regards, RockRat (disclosure: long)

Dew,
Here's a question.
Who will do a PIPE first, MNTA or NBIX? Both now have no drug prospects and cash is less than most people expect. Plus both have overvalued stock prices.
Please advise.
Thanks

Pretty cowardly of ThomasS and Dew to not show up. Make false accusations about problems with IND and then when it appears, they hide. Dew is probably trying to analyze how he can pump MNTA elsewhere to keep it from going to its cash value of $2 given their main shot was not approvable.

Is Thomas going to show up to spin this negatively? Is Dew going to show up to talk about a black box warning for something or other?

i agree with ymaxx. long run this worrying is pointless.

The henny-penny arguments (as echoed by io_io) are perpetuated by people with no substantiative, if any gains, of their own in the sector.

Recently on a flight from Chicago to NY, i saw a fat 5'6" long island guy telling Dan Reeves at the gate (this was after a Giants/Bears game) that the Giants should get rid of Plaxico Burress. Dan Reeves looked at the guy and said, "which of the other 30 teams that would kill for him should they trade him to?". That fat guy are the henny-pennys of this message board.

Thomas you are retarded,

Top line fibroid data means data from the 1st cycle of the 2-3 cycles. hence it happens earlier than halfway through the trial b/c it is prior to holiday period and subsequent periods.

Do you really put forth this much effort to not understand this?

"What about Palo Alto which has increased their holdings in the latest report. I have met them including one MD on the staff who is high on MNTA. They struck me as being as good as any biotech investors I have met. (Present company excluded of course.)"
-Were these the guys sitting in on the patent trial who were high on it in the 20s?

I wouldnt doubt if Orbimed is out of a lot of stuff. I am hearing their performance hasnt been so good and there are potential redemptions.

"Is it typical for you to short a stock where you have done essentially zero DD on the company?"

i) Sounds like a pot trying to call a kettle black with regards to your comment about a black box warning for Proellex.
ii) Pls succinctly outline an investment thesis for MNTA

One is me.
Here is how I see it:
This stock fell to $4 on the NOT APPROVABLE decision. They had over $3 in cash at that point. Now the stock is $8 and they have less than $3 in cash, pro forma for Oct-Feb burn and a more reasonable payables #. How are they not going to have to do more trials if ENCY, in the same position as them (said no new trials, FDA said yes to new trials and FDA WON), got an APPROVABLE LETTER and still lost and had to do new trials. Other stuff is preclin. EMIS, FLML and other "formulations" people have had no success. I think it goes to $2 in a year or so. Plus no smart healthcare institutional money in this, except Orbimed but theyve been pretty shaky lately.

LMAO someone lifted 1k at market and took it from 8.96 to 9.20. If/when someone new comes in for size we should rocket (presuming the shorts dont dump another 1.3 MM additional like last time).

i think we will see an improvement in the website soon.

Thomas, not sure if you are hiding on your MNTA post but fyi MNTA now has about $2.50 a share in net cash once you include the Oct-Feb burn rate, paying down debt and excess of payables over receivables and they are burning more than %0.50 per quarter. So cash position is not a positive investment thesis. What am i missing?

You should be nicer- i (and a lot of others) thought the new presentation was a lot better- some people spent a lot of time helping the company on it (and didnt get paid).

I think that speaks to the strategy out there by a non-fundmental group of healthcare investors and that is to short all companies who are doing a financing or look to be running low on cash and a financing will likely be in the cards. On the case of VRTX, i presume the shorts were taken by suprise that the deal was completed so fast without a prolonged roadshow.

"Pls don't misunderstand, there is a distinct difference between my "negativity" and my lack of making "assumptions."
I dumped RPRX in early Nov at a substantially higher price than this for 1. better opportunities, such as MNTA"

Thomas, what is the basis for your positive inclination on MNTA that it was a "better opportunity"? They probably have 30 MM less cash now than as of 9/30 balance sheet you may be citing so they could be well below $4 per share in cash with no products or no hope. Why will this not go to zero in a year or two?

I am confused- you saw Joel Sendek from Lazard Freres or you saw Matt Kaplan from Punk Ziegel. Which one said they liked the story? matt knows it well, covers it and has a 25 PT. Joel has historically stated he doesnt know the story well- if it was Joel, perhaps he spent some time learning it in recent month(s). let us know which one it was.
thx

i think people can access it via BIO CEO website.

I read somewhere that the costs to get in are thousand(s). I will just listen on webcast.

I encourage people to listen to this presentation.

Barring no impending news or a lack of need to get in immediately, if it were me i would be buying some each day with low bids or volume weighted average price (VWAP) algorithms. If i wanted to get in i would be periodically lifting. Plus a fund may be contacted by a broker who has a block for sale.

That is what is so confusing to me. I suspect one fund is out (and i think they fully didnt understand the company that well) but they sold piecemeal each day slowly driving it down- if they wanted out they should have contacted the known buyers like Efficacy, etc. if i am right on which fund it is and they are out, it just goes to show that once you get big enough as a fund, quality suffers b/c you spend too much time fundraising, managing positions and trading monstrous position sizes that fundamental work suffers.

i suspect one large holder is out. we will see in a few days.

Short interest down slightly= slight surprise.
Some long capitulation?
Perhaps our friends on the board who were talking about black box warnings, a near-term financing or a stock that was headed to $4?
I know of 4 funds accumulating. Looks like the capitulation selling is over.

ANy guesses on new short interest as of 1/28 which will be released today. As of 1/12 we were 1.389 MM. I bet we're over 1.5 MM.

I would go if I could just go and crash it- does one have to be signed up?

Io_io want to meet there?

>
docbanker, what would you guess is the legimitate free trading float of this, after all the larger sized retail, insiders, and institutions are taken into account?
<

---I have a guess but prefer to think about it this way: Someone legitimately buying perhaps 70k shares (total volume was 105k) drove it up almost a dollar. I like to be disciplined about entry points: being a buyer at X and a seller at Y, but there is a certain class of investor who gets "beer muscles" when a stock starts going up and will buy at that point when they see others buying. So the number of shares for sale is more of a range- under certain circumstances when news may come or there are other buyers it is less than when we have no news (in this scenario it pops rather quickly but if the buyer backs away, sellers will come in so the number is higher).

Price action yesterday and lack of selling today tells me that the bullshit dribbling out of shares in the 8.50s and such over the last few days is shorting. Anyone in their right mind who had to get rid of shares would have sold strongly into strength and we are not seeing that.

My guess for short interest for 1/28 trade date (released 2/11) is 1.6 MM up from 1.389 MM and I think we are higher than that now.

Well, I guess that answers my question. Your wit and wisdom are missed here, but I assume you are getting paid such huge sums of money for your insights that it makes no sense to provide them in a forum such as this.

As an aside, and related to your "point of interest", I've had several phone calls with Dr. Van As concerning my wife, who has endometriosis. During a particularly bad flare up, I suggested to her that we consider entering the endo clinical trial. After a couple of conversations with Dr. Van As, including a commitment by me that I would sell my shares if necessary, my wife's symptoms abated somewhat and she decided she'd rather not be a guinea pig. Dr. Van As, by the way, could not have been nicer.<

----So that's why Andre was so slow in submitting the protocols for the new trials; he was on the phone all that time. LOL. Glad your wife is doing better.

----On a side note, I met a few women coincidently who are in this Neurocrine trial and i'm pretty sure its a Lupron (GnRH agonist) vs their drug (GnRH antagonist)- either way whatever arm these women were in they didnt seem too excited about the efficacy.

>I assume you are getting paid such huge sums of money for your insights that it makes no sense to provide them in a forum such as this.<

>Ha! I'm no docbanker

Just kidding, docbanker.<

---- I'm sure you're doing great- your case studies of your work looked impressive. Frankly, I wish we had you on our team and I apologize for the Company not getting back to you- I am going to take them to task next time I see them for that. In spite of them not getting back to you, I believe after a few "come to Jesuses" as I call them, the company is starting to believe that having great clinical compounds on its own is sometimes not enough to overcome a poor IR effort and poor media/publication effort and I am seeing improvement in that area.

Good luck to you.

Was this the same person who pumped MNTA in the teens?

one of the directors on the board of rprx.

NOLA Masterson buys 500 shares.

People this is a big deal as she bought 100 shares last time (when we were in the 5s).

On a serious note this is good b/c it seems her purse strings have been a bit tight historically- someone must have gotten her purse out of the vise.

I dont recall talk of a Japanese partnership pre-empting another partnership.

I will reiterate that it looks to me like cash burn is lower than expected so we have time as well.