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Gregory Pepin

 
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  • AB Science : When Analyst Don't Get It .... [View instapost]
    pretty clear and obvious how bad does the SG analyst sucks :)
    Dec 27, 2012. 06:01 AM | Likes Like |Link to Comment
  • AB Science : When Analyst Don't Get It .... [View instapost]
    Yeah true on that one but the low end of the limit being 25 just demonstrate the incompetency of the analyst...
    Dec 19, 2012. 10:39 PM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    It takes up to a year i think.
    Dec 13, 2012. 05:02 AM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    Ok thanks sorry for my wrong interpretation
    however I expect that the safety will be better (much better in fact) with masinitib.

    anyway due to the tough cancer we are talking about, more then 2 treatment would be great
    Nov 13, 2012. 02:17 PM | 1 Like Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    the SPARC score patients is i believe the 33% subgroup in which AB science isn't targeting with their product.
    Nov 13, 2012. 10:52 AM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    My answer on celgene data is just above your comment ;);)
    Nov 11, 2012. 06:10 AM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    Celgene just announced statistical significant data on pancreatic cancer. That is a good news for patient but I think overall survival improvement is probably very limited (lower then AB science).
    I believe that because :
    - they raised the amount of patient enroll (and finished with over 800patients) the more patient they had the less the difference of survival has to be
    - if they were a big difference in survival (in the tune of 6 month for example Masinitib concerning that 65% population) the study would have been stop very early for ethical consideration
    - they would have issue an even more aggressive release if the efficacy was really impressive

    Also on top of that the toxicity is infortunatly pretty important on celgene product. I assume when AB will do their confirmatory study on their subgroup the study will end very quickly and won require 800+ patient to show statistical signicancy.

    So celgene news is a good news for pancreatic patient but I think they will be inferior to AB science both in safety and efficacy (at least on the subgroup they identify.) I think the number of patient they enroll was clearly a good math calculation to get statistical result despite a small increase in median OS (heck it is still an improvement and it is great even if safety isn t great )
    Nov 10, 2012. 02:19 PM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    So we could say that the approach of AB science with a simple blood sample gives them an amazing advantage to find out the right treatment for pancreatic patient ?
    Nov 9, 2012. 05:48 AM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    Those are very good question. I'm going to answer them below : (copy paste your comment)

    - EMA might not like the retrospective analysis of their stratified population.

    That is a real short term risk to consider. AB Science took the approach to define the stratified population from an overall general population. They couldn't do different anyway and had no choice. Now the EMA (and FDA) could simply reject that approach in the short term by asking a confirmatory study and provide no conditional approval until the study is done.
    However, that is a pure short term risk and AB science should be look at as a great long term buying.
    The confirmatory Study that will anyway probably done (since it would also be mandatory with a conditional approval) will most likely be very fast and won't need full enrollment due to the significant difference in survival that will lead to probably a quick closing of the study).
    Remember two elements: HR and the p-value. Those two elements just confirm that it is just a matter of time to get it approve.
    will it be :
    - Conditional Approval + Confirm study + Full approval following
    - No conditional Approval + Confirm Study + Full approval following ?

    Won't change much as it will end up with full approval within the next 24-36month top i would say. Odds of success : 1-p-value = 99,9996% so we are pretty good here)


    - EMA might find the number of patients tested in this population a little to low (320*0.65 in phase III = 208 patients, only half of them treated with the experimental drug... only 100 patients at the end of the day)


    Well, Pancreatic cancer being a very aggressive disease that has no real treatment and considering the solid benefit and the good safety profile. I think you won't need to enroll thousands and thousands of patient because you have a very solid p-value and a great HR. I would expect the confirmatory study to be around the same size as the primary pancreatic study however i would think it would be done within 12-18month due to quick differentiation that would force the study to be done earlier for ethical reason. (Big difference in death rate for example between placebo and non placebo).

    - No marketing / sales force... so it might be difficult to maximize the profits if they want to keep control of marketing and sales.

    Agree on the risk of marketing. Now two elements to keep in mind :
    - Pancreatic cancer treatment provided by AB Science comes in complement to the one in place so they won't be any "negative competition" from Gemcitabine but in fact probably help from it as it would also increase revenue for Gemcitabine.
    Also, Pancreatic Cancer being so aggressive it is most likely easier to get to the patient then other disease because the clock is ticking and i would assume patient are more aware (or become more aware) about clinical options.
    Finally, we shouldn't exclude licensing either however, licensing AFTER approval provide a great share of revenue that is much more favorable to AB science (50/50? even better since they control the supply chain).

    - What about pricing & reimbursement? Even if masitinib gets approval in EU, there is no guarantee that it will get reimbursed by public healthcare systems, given the small number of patients in phase III.


    Cancer being a priority and Cancer pricing is pretty much set by healthcare systems. I wouldn't worry about that. Keep in mind that the cost of development AB Science occured to develop their product until approval is pretty low compare to the industry standard (we won't reach the 200Meuros spent for all the application to be approvable) therefor they are much more flexible in term of pricing then we could think. Cost of production being most likely very low, return will stay pretty high.
    Now I would expect the product to be a grade A drug so you could expect cost around 30 to 50Keuros fully reimburse due to the high benefit it provides and the high priority cancer has and the orphan drug status it carries;)


    - Finally, what about the US market? When do they want to submit, how are they compliant with the companion diagnostics regulations, what is their sales force there?

    I assume they probably are in discussion with the FDA. Now being a Euro company probably makes advancement less easier then being a US company. It is the same for US company toward EMA (Check ONYXX for example, they have conditional approval in FDA for one of their drug but need to do phase 3 with no conditional approval in europe).
    Now the nature of the disease we are talking about could make things easier for AB Science but I think the FDA and the EMA will follow at the end if you have a vision of 24-36month. Now in the short term, hopefully they are talking with them and hopefully it will end up positive and similar to EMA position.
    Now for sales force etc. I would duplicate my answers for EMA. Markets are similar etc. Now for reimbursement, the process is longer but considering that Meds such as Dendreon product has opportunity to be reimburse, I don't see any reason why a drug with an HR so great wouldn't be reimburse too. Orphan Drug status helping its case a lot ;)

    Overall i would say that the HR and the p-value (same for GIST) just indicate that now it is only a matter of time before success (meaning approval) so any investor willing to hold onto their shares will be greatly reward. Now in the short term there is a lot of potential news catalyst that could accelerate the run up such as FDA situation, other data, ASCO presentation, EMA position, New studys underway, Vets collaboration or development etc. etc.
    Nov 9, 2012. 05:48 AM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    Just to answer your remark :
    - We are talking about Pancreatic Cancer, and not Prostate Cancer or anykind of cancer that has already tons of treatment available.
    - The real data people should look is the combinaison of Masinitib and their diagnostic system. Both together allow to know which group you are in and therefor expend your OS Median.
    - Concerning side effect, well we know toxicity of AB Science Molecule is good because it has been approved to be tested in non oncology and also on top of that, the GIST phase 2 (2nd Line) trial showed safety data better then Sutent with a statistical significancy.
    - I agree with you that "the common" investor will not look beyong the "overall population" whereas the clever one will look deep and see that 100% of the population is concern by AB Science :
    35% using only their diagnostic system
    65% using the diagnostic then the treatment....
    And by the way 65% for a sub group, that is pretty impressive....
    Finally, they always said they would add a genetic study at the end of pancreatic phase 3 study, that is a clear message that from the beginning they knew they would go for sub-group and not overall population but they probably had to go for the overall population to figure out the sub-group. I wouldn't be surprise (I would even expect) a follow up Phase 3 study on subgroup only that will show this time "Efficacy" for the entire population so that the "common" investor will be happy... too bad he will miss the buying opportunity the "clever" investor will have already see by reading in details the data.

    I think long term is looking pretty good here... :)
    Nov 5, 2012. 07:56 AM | Likes Like |Link to Comment
  • AB Science : The French Exception ? [View instapost]
    Going for an ADRs listed US Exchange now would be expensive and a waste of short term money. You should see the low valuation compare to the true long term value as an opportunity to take advantage off. Eventually the price will rise to the real value of the company that is much much higher.

    AB Science could qualify for it i guess BUT :
    Remember, the overall population went negatif (or should I say not stastitical significant) so due to that, you can only go for the conditional approval (for the sub group) since the full approval request that the overall population is positive.
    On the positive side, we know, thanks to the amazing p-value that if - and they will probably do it - they do a confirmation study focus only on the sub group that succeed, the overall population will be positive on that study and therefor they would be entitle to request full approval with fast track process.
    Now the other good news, due to the very tough death rate of that disease, the phase 3 focused on the sub group would be very fast (and they could still get along with the phase 3 underway the conditional approval).

    Concerning the US FDA, I assume they are in discussion now for either compassionate usage or conditionnal approval like with the EMA. But again, as soon as they get a phase 3 result (that would be fast again due to the nature of the disease) positive on the overall group because of the biomarket and pain criteria as the focus of enrollment. They will be able to go all-in in term of approval with both EMA and FDA.

    THE MAIN THING TO UNDERSTAND :
    The sub group is pretty big (we are talking about 65% and 35% patient that are "independant" even if they do overlap also). That is a very big market
    The P-value (especially for the 65% subgroup) makes the success of a potential confirmatory study on the subgroup pretty much certain...
    They will eventually succeed in getting approve on that subgroup because both efficacy and p-value is huge, just a matter of time...
    For long term investor time is your friend ;) take advantage of it.

    Also, I'm pretty sure, they have the diagnostic tools or mechanism and i'm pretty sure it is a easy and fast process or they would have specify it since it is more then important in their success and on top of that, they cannot have a long diagnostic process due to the very low median OS.

    I think more surprise will come on that study.

    People should ask themself, what did they patent ?
    My gut feeling : The biomarker they found and the diagnostic tools link with it.... :) would make sense..... no ? :)
    Nov 2, 2012. 06:16 AM | Likes Like |Link to Comment
  • Hard-luck THQ (THQI -10.1%) plunges yet again following its FQ4 report. Though results beat estimates, fears continue to grow that the game developer no longer has the scale to compete with larger rivals, following recent missteps. A sub-$1 stock price is also leading to worries THQ will be de-listed. The company is hoping upcoming releases for its Darksiders, WWE, and Saints Row franchises will help drive a turnaround.  [View news story]
    Anyway time will show that the turnaround of THQ will be successful (at least compare to actual market Cap)
    May 17, 2012. 08:22 AM | Likes Like |Link to Comment
  • Hard-luck THQ (THQI -10.1%) plunges yet again following its FQ4 report. Though results beat estimates, fears continue to grow that the game developer no longer has the scale to compete with larger rivals, following recent missteps. A sub-$1 stock price is also leading to worries THQ will be de-listed. The company is hoping upcoming releases for its Darksiders, WWE, and Saints Row franchises will help drive a turnaround.  [View news story]
    it is a screaming buy......
    May 16, 2012. 11:10 AM | Likes Like |Link to Comment
  • AB Science : A No-brainer Long Term Buy [View instapost]
    Thank you for your feedback.

    Well of course we would all love to see Pancreatic Cancer data earlier then later since they are the most "difficult" one (over the 9 phase III underway).

    However, I do see a bright spot on that study. I don't recall any Phase III study in Pancreatic that has been able to go until the end which seems to be the case for AB Science.
    I don't know if it will be anything in term of data but at least it is unique by itself to be able to get "final" data in pancreatic Cancer.

    Now, you are right, their approach is mainly the big reason why it will probably work. They are very cautious and go step by step and maximise 1 drug before moving to another target. By doing so, they also reduce significantly cost of development. They probably have a great screening of molecule in order to pick such a great one like Masintinib.

    I think, and we both agree on that, time is the main power here. Any dip should be consider as a buying opportunity over long term. Right now there is a clear long term arbitrage to do on that stock by buying it and holding it for a couple of years.
    Mar 16, 2012. 10:45 AM | Likes Like |Link to Comment
  • IPO Preview: Union Agriculture Group [View article]
    Would be interested to know it if you happened to find it tonight ;)

    Thanks
    Jul 26, 2011. 05:38 PM | Likes Like |Link to Comment
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