AI
Friday, February 15, 2008 9:38:45 PM
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
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
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)
