PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

I just looked this up and indeed, it looks like that would be the case, as far as the mean change in GFR placebo looks decided better than galafold.

However something that is not clear is whether this data relates to general Fabry patient types as a mixture of patients with and without amenable mutations.

Later in the report when talking about GL3 levels of reduction in kidney. it states that the difference in GL3 reduction was not statistically significant between galafold and placebo, BUT that when a post-hoc analysis was done of the amenable mutation patients, it did show a statistically significant benefit over placebo. And no benefit in patients without amenable mutations.

Therefore, while I don't see the data here, I would still believe that galafold does work in a statistically significant manner for amenable mutation patients on their GFR rates too. However, even within the provided GL3 reduction number, the data was as follows.

"A post hoc analysis at the end of the double-blind period (six months) was conducted in the patients with amenable mutations. The change from baseline analysis demonstrated that six months of treatment with migalastat was associated with a statistically significantly larger reduction in the average number of GL-3 inclusions per interstitial capillary compared with placebo: –0.250 ± 0.103 versus +0.071 ± 0.126, respectively; P = 0.008."

If we compare this benefit over placebo of -0.321 reduction of GL3 inclusions in the kidney, to the PRX-102 reduction of -5.4 from the Phase I/II trial then we can clearly see the chasm of difference in benefit provided by PRX-102.

I understand that we can compare these two numbers as the PLX presentation shows this -5.4 based on the BLISS score (Barisoni Lipid Inclusion Scoring System), which was also the scoring system used in the galafold trial, as you can see from this webpage and searching for BLISS.
https://www.karger.com/Article/PDF/431051

This would again hopefully translate to the ability of PRX-102 to take a sizeable chunk of galafold's market share. Though that really isn't the part of the market that we care about that much, as they a aiming to achieve 85 million dollars sales by end of this year. I'll take it, but it's a relatively smaller piece of the pie.

I would wonder if CC might be being paid by any of the current Fabry product providers. If the data continues like this it will indeed negate the need for competitors' products for a great majority of patients.

I had a look at your Geron request. Looking at it, it's hard to see what data to trust. From the Yahoo page: https://uk.finance.yahoo.com/news/apos-why-geron-plummeted-69-140500559.html
It looks like the product started with 54% compared to 34% placebo, but then with additional sample product dropped to 28%. So I can see why that would have spooked JNJ. It appears Geron is going to go at it anyway into Phase III and see what the final answer is. But I can see that investors don't like that as it will mean high cash burn and with a high profile JNJ drop-out, may need some good convincing to get a new partner on board, big or small.

Also agreed though that again it doesn't make sense where PLX's SP is, Geron has a Phase II product that has been ditched by JNJ. Meanwhile PLX has a Phase III product with so far great results, has the cash to get them to approval and has a global partner for US and ex-US markets committing over 1 billion dollars. And on top of this has other Phase II products in OPRX-106 and 110, of which while some may feel 110 could have confusing data from the Pulmozyme washout, the OPRX-106 data is quite clear on it's performance. I'm again dissapointed though by this share price depreciation seen each time after the great clinical data comes out. Looking forward to finalising these Phase III's with what I expect to be great data and seeing this SP get to where it belongs with a multi-billion market cap valuation.

Separately, I'm curious to what people extent people think the shareholder meeting news to increase the authorized share count from 250,000,000 to 350,000,000 might have had on the share price depreciation? I know it's an increase of 100,000,000 shares. But it would seem presently that PLX doesn't need to raise cash. So why do we think this is on the agenda?