Replies to post #3289 on Repros Therapeutics, Inc. (RPRX)

[DewDiligence]

[OT] >[MNTA] 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.<

There is no such thing as an approvable letter for an ANDA.

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

[zipjet]

Hi Doc,

Can I play? :-)

Re: MNTA

>>This stock fell to $4 on the NOT APPROVABLE decision.

Technically it was a Not Approvable letter. But that is not the same as what we are used to on an NDA. It is possible that a complete response will be filed and accepted by the FDA. I will come back to the "why" it might work later.

>>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 #.

CEO says that cash will carry them for two years. He also claims that they will partner M118 this year and end the year with two years of cash, presumably due to the partnering contribution. We are told that the discussions to partner M118 have already started and will be closed some time after the PIIa results are in.

>>How are they not going to have to do more trials

Good question. Keep in mind that the issue is around the immunogenicity of enoxiparin and m-enoxiparin. Enoxiparin is immunogenic in less than 1% of cases. IF I have this right, a study that was powered to demonstrate a statistical difference in immunogenicity between two compounds that are the same would be impractical. IF I have that right, there will of necessity need to be another way around the immunogenicity issue other than clinical trials. One possible way would be to construct something along the lines of a non-inferiority class study. But even that would be a big study if I understand this. If there are statisticians out there who want to educate this lawyer I would welcome it.

>>Other stuff is preclin. ... no success.

You might want to take a look at M118 if you have not already done so. It looks attractive.

>>Plus no smart healthcare institutional money in 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.) :-)

Kind regards,

ij

[Jonathan Robinson]

OT MNTA

Orbimed is out at this point.

Jon

[io_io]

I think MNTA is interesting, but over-blown on these boards.

Over-blown, because the pipe-line isn't half what DewD makes it out to be be. Note that no-one in months of posting has come up with a theory as to how the Copaxone patents might be over-turned, nor how many years that might take. Also, despite price increases the drug just had a hefty 4% Q-o-Q decline (not just Rx, but $ sales) in the USA, as Tysabri starts to flex it's efficacy muscles. Plus it's far more likely that oral MS drugs with better efficacy will arrive before any patent resolution, much less a successful ANDA.

I think MNTA investors on these boards should look at the MNTA pumping in the light of this generic Copaxone hype - this aspect of the pipe-line is among the most thread-bare speculation I have ever seen supported for months here. Like it has no basis in reality at all. If the other candidates are dressed up with equal BS, then caveat emptor.

However - MNTA is indeed interesting because it would have first-mover status, and there may be some political wind in the sails. In a way, it is pure biotech - it asks, "shouldn't the pharmaceutical world change for the better ?".


By-the-way, whenever DewD posts about shorting, I am reminded of his "averaging-up" on a DNA short in late '03, and another gallant series of "re-shorting" DNA trades in early '04. You can probably find the story by searching on BV. Definitely some short trades that until then I did not find imagineable.