RE:RE:The VoucherHow can anyone expect a voucher prior to a BLA? It is only a possibility considering the pdiatric designation, and honestly, I don't believe anymore about a voucher after how this BLA demand has been handled by the FDA so far.
We had a rolling BLA, an Orphan drug designation, a pediatric designation. The FDA are the one who ask to stop the tria earlierl and submit the BLA demand because of 100% success rate with no safety issue.
We the had a priority review (6 months instead of the usual 10). After submiting the last module of the rolling BLA on april 3, 2017, we finaly end up with a PDUFA date of april 14 2018, more than 12 months later! talk about a priority review!
Now we are postpone until somewhere in Q1 with absolutely no precise guidance about that meaning it could be anywhere between January 2019 and july 2019!!!
At this point Prometic might have an IVIG BLA in Canada before the Ryplazim BLA with the FDA.
Considering all of the above, I don't believe anymore that the FDA will give a BLA once Ryplazim is approuved. I don't think the FDA cares about Prometic, a small canadian company. Considering how much money is worth the pipeline, I even wonder if these delay after delay are not because of some sort of lobbying by the competition or any other sharks to put Prometic in trouble and get them for cheap..
After all, Prometic is a small fish in a tank full of shark and that's why I believe more than ever that Prometic need on of these shark as a protector. Sign a deal on 4050. Even if 4050 has a potential worths in billions, if Prometic gets a smaller share of profit than expected but get a large enough upfront to keep 100% of PPPS and be able to hve the cash runway until it becomes cash flow positive, it will still worth a total of billions of revenu per year mid-long term for Prometic only.
With no partner in our back with it's influence, money, worldwide footprint for marketing and network, all this amazing pipeline might not make it to the finish line under Prometic's name.
Time to monetize a part of the pipeline and create a win-win situation.
The nomination of Bruce Wendel is a sign for me that Prometic is trying to bring a new momentum in order to finalise a deal with one of the prospective partner.
IMHO, the goal should be before the beginnig of the IPF trial or even the AGM in order not to arrive empty handed on how the plan to fund the year to come and the trial.
But of course, it could also be a bought deal if they can't reach a deal.
Anyway, the next ouple of weeks should bring us an answer, and if they finalise a deal, there will be a huge mood swing.