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Re: None

Monday, 04/10/2017 12:20:37 PM

Monday, April 10, 2017 12:20:37 PM

Post# of 3353
Hi thesaud,

First, indeed I saw that article when it came out about an hour or two before your post. And I don't think it's all the doom and gloom scenario this basher is creating. And yes I believe that is the case for the person as he/she brushes over things a little too easily, while trying to emaphsise on anything they can construe as negative.

Before I go into why this isn't the 'terrible' news people might be led into thinking, is that I also find it odd that this board is incredibly active almost everyday while everyone's saying great things. Then one article that gives a negative spin and not a peep from anyone in the last 4 days??? I do hope we're not burying our heads in the sand??

Now onto why I, in contrast with this 'Titan', believe BCLI is fine is based on the following.

Effectively his case is resting on 4 things (really just 2 though).
1. That there are is an increase in post therapy G-tube use
2. This person's implication that not using FVC and only ALSFRS-R meant that respiration wasn't taken into account, and that FVC is almost a key metric for ALS progression.
3. After the stellar results of 2 and 4 weeks, that come to 8 weeks and the mean change in slope is worse than placebo, this implying poor viability of treatment
4. He again says low optimism because the data is only based on the aforementioned ALSFRS-R metric.

Aside from his point 1 on increase in post-therapy g-tube use, he's over inflating and quite frankly even creating nonsense. And anyway on the point 1 where he merely point to the data, this was already a key mention on the slide and so isn't something that BCLI is hiding, as he/she is insinuating and BCLI is well aware of it, so he/she can stop assuming that they are trying to fool the investor community.

On point 2: This implication of FVC not being included as a metric and therefore not taking into account respiratory function progression is nonsensical if he/she did his/her basic research. As you can see in many areas and in this article, from 1999 (http://www.alscareproject.org/whatisals/als-functional-ratingscale-r.pdf) is that yes, the original ALSFRS metric did not include respiratory function HOWEVER, BCLI is not using ALSFRS, instead BCLI IS USING the ALSFRS-'R' metric! This is the revised version and the reason for it's revision was to specifically INCLUDE respiration as a factor in this scale. SO YES BCLI is taking into account respiratory function.

Quote from the above link research paper (which is also quoted in other relevant ALS literature)
'One weakness of the ALSFRS as originally designed was that it granted disproportionate weighting to limb and bulbar, as compared to respiratory, dysfunction. We have now validated a revised version of the ALSFRS, which incorporates additional assessments of dyspnea, orthopnea, and the need for ventilatory support. The Revised ALSFRS (ALSFRS-R) retains the properties of the original scale and shows strong internal consistency and construct validity.'

Also in the litarature ALSFRS-R is the key metric that is used in all major ALS studies, where FVC is only used as an added component, as this is respiration is taken into account in ALSFRS-R


And two quotes from another research paper from 2014:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4305209/
'Functional Assessments

Survival measures may also be insensitive to potentially significant changes in functional status. All of the major trials in ALS have included a functional scale as a primary or secondary endpoint. The revised ALS Functional Rating Scale (ALSFRS-R) is most commonly used, and evaluates symptoms related to bulbar, limb, and respiratory function

'Respiratory Muscle Strength Testing

Measurement of respiratory function has been included in most[NOT ALL] major ALS clinical trials, and may be easily performed in the clinic setting using portable spirometry units. Forced vital capacity (FVC) obtained at baseline may predict the rate of progression'

So I think we can largely do away with that respiratory concern.

On point 3: The author points to a graph that he/she allude to indicating poor results happening after week 8. This is because the bars appearing lower in MSC-NTF are lower than in placebo.

Well of course you're going to see that at some point as the treatment wears off, but it is that now the treated patients are starting off from a different and much better/higher baseline, than those that were on placebo! Please take into account he Y-axis. This is measuring the change on the slope over time. Now of course the MSC-NTF slope will have a faster decline once the therapy wears off, BUT THIS is becuase we are starting from a much higher baseline, so we will inevitably see larger drops, compared to someone who didn't get treatment and has been progressively getting worse but from a much worse and lower situation/baseline.

Also BCLI knows that the treatment is wearing off after 8 weeks, and thus their protocol for Phase III is to investigate that as a time-point for the new injection of cells.

So first the treated patients are on a much better baseline over time, and this 8 week time-frame means the patient will need 6 injections per year to effectively stop progression of his/her disease (this also within dependent on the fast/slow progressing patient type, which BCLI and ourselves are also well aware of and not hiding). I think these patients will be more than happy to have the relative inconvenience of 6 injections per year if it keeps their horrible disease in check.

So I think we can get rid of that concern.

On point 4: This effectively re-iterates the difference he/she hasn't grasped between ALSFRS and ALSFRS-R.


This person, either has an agenda to push the stock down, which they were successful in (again using lack of reaction on this board as a proxy for that), or he/she isn't paying attention, or quite frankly both or just plainly can't read graphs. These finance 'Titans' chat nonsense. Let us not forget Warren Buffet's obliteration of top dollar hedge funds that gave only one quarter of the return than a nobody investing in the S&P 500 and sitting back lazily would hade made.

I'd hope this 'Titan' would retract his/her poorly researched article and despicable insinuations of a company that could potential save people's lives with a disease that he/she doesn't appear to pay enough attention to.

All my very honest opinion




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