I do recall Moshe and Yossi mentioning on more than one earnings call that results would be expected in 2019.
I just checked the March 6 2018 webcast earnings call, and they mentioned that a conservative time estimate for readouts on all trials would be 2019.
Also they mentioned on 2018 Q1 call that with all the 40+ clinical sites enrolling that they are not planning on bringing any more sites on-line as recruitment is even going better than planned.
They also mentioned on the March 6 call that they already had all the cash needed to get to 2020 and that was before the Chiesi US deal, and other milestone payments due from both of the Chiesi agreements and without other partnering that may happen for example on OPRX-106.
Since they the obviously did get more money from the Chiesi deal as well as more in terms of set milestone payments prior to PRX-102 approval and then also mentioning that dilution was not presently on the horizon for them as they have the funds to cover their debt. So they should definitely be funded to at least 2021, which should definitely get them to PRX-102 approval and hopefully revenues from this product. Also on the debt situation, I do believe they can re-negotiate the terms of the debt as they have done before and push it back a few years until the SP is in a better place and decide what proportion to pay in stock vs cash. If the stock increases significantly it may be in our interests to have stock used rather than the cash they have on hand.
I have been going ever deeper into PRX-102's data and relevant online research articles and am ever more convinced of its potential. I believe they made a good call with Chiesi in terms of having a partner whos benefits are aligned with theirs.
From the clinical trials websites, completion for the trials stand at:
Balance: June 2019
Bridge: September 2019
Bright: December 2019
Of these the most important, largest sample, and longest running and thus most data for FDA and EMA approval is the Balance study. With expected completion in June or maybe even a bit later but still in 2019. While we should have the data by end 2019, actual FDA and EMA approval times would likely mean potential approval in 2020. So as long as the data is good in 2019, which I strongly feel it should be, then the stock should see a very nice boost while awaiting actual Regulatory approval rubber stamping.
I would also very much expect the supportive Bridge data to be available in 2019. Given the May 2018 Warnock poster, it would seem very much that there is a benefit of switch from agalsidase-beta (Fabryzyme) to PRX-102. Therefore given that Replagal in the Bridge study is effectively the same enzyme from the the same recombinant DNA, just with a few differences in post-translational modifications that seem to impact on dosing. Then one would very much expect to again see benefit from agalsidase-alpha to pegungalsidase alpha (PRX-102). Especially as PRX-102 is a pegylated form of agalsidase-alpha.
Thus this with Bridge and Balance data very much expected in 2019, things should look good, vis low chance for upcoming dilution, reaching data, share price up, then approval with share price up again.
Finally, as mentioned the Warnock poster has already provided data on benefit of switch from Fabryzyme vs PRX-102, so hopefully the Bright data is more a formality of simply compiling more evidence that we seem to have for benefit against both Replagal and Fabryzyme.
