RE:RE:RE:still interested to her from investors re estimate of spSerious partnering
1-no need partenering for the Plasminogen for shure , just waiting for the FDA permit.
Pg trial finished,production going on, seller team organised and ready to deliver RYPLASIM.
For this one the longs ,the patients,the familys,the doctors,the hospitals,all are waiting for the benefits of all kind ,including dollars.(we are still in a capitalist systhem)
2-PBI4050 ,this is the one that is less predictable for lots of reasons.
when PLI asked the FDA for trial for IPF,they say yes but we want you to do 2 more trial simultaniously combi 1 and 2, one with Perfenidone and one with nintenadib.What was there idea at this moment????
We know, now, that they accept PLI to continue the trials but without Perfenidone.That prove that the FDA is not satisfy with the long term results of this drug ,PLI will certainly not do a partnerring with Roche on this.
Remember Roche paying 8 Billions for this drug.
Now PLI will continue with the other one as accepted by the FDA. Boeringer understand that (as soon as PLI began the trial) a competitor with there drug will be in trial with the FDA !!!!!!!!,and they just have to wait for the results?????
More than that they will do trials with those patients who can't support the other 2, because of sides effects .
In this context ,who is in control of the situation ??? I think that in the IPF sector we will see PLI becoming the leader for several years, its clear when we look at the charts from the ascend and inpulsis studys and looking at the blugs of the patients ,its obvious that they are also waiting for the new kid on the drug (on the block) .
So i think the big investors are looking more in that way than trying to put the exact date for the BLA response,even the FDA can't tell you and if they can it is because it is imminent .
We just recently learn that they are way behind there scedule ,so what is really happening behind there wall????
Just my opinion