RE:RE:RE:RBC Barcode thanks for the added colors and context on this. I guess; as this important date is getting closer some, me included are getting maybe more edgy than usual.
Basically what Doug from RBC is saying is what was already computed regarding our chance of approval by myself and few other, nothing is 100%, but using FDA statistic one can at least try to get a feel on our odds of seing Ryplazim approved on first attempt:
Eric40 wrote:
eric40 wrote: only about 11% of rejected BLA are CMC issues (Chemistry, Manufacturing and Controls).
CMC includes manufacturing but only a part of CMC rejection is due to manufacturing.
BLA's rejection reason
1-Efficacy deficiencies only: 31.8%
2-Safety and efficacy deficiencies: 27.2%
3-Safety deficiencies only: 25.8%
4-CMC alone: 11.3%
5-Labeling alone: 2.6%
6-CMC and labeling: 1.3%
Of the unsuccessful first-time applications, around (15.9%) included uncertainties related to dose selection, (13.2%) choice of study end points that failed to adequately reflect a clinically meaningful effect, (13.2%) inconsistent results when different end points were tested, (11.3%) inconsistent results when different trials or study sites were compared, and (13.2%) poor efficacy when compared with the standard of care. This breaks downs of #1 and 2 includes also some safety concerns.
These statistic are based on a 10 year period. These number can change overtime.
For Plasminogene, walk in the park IMHO
Read more at https://www.stockhouse.com/companies/bullboard/t.pli/prometic-life-sciences-inc?postid=27607926#cw6PEZKFsYXCV7B3.99
MoneyCristo, Edited wrote:
RE:RE:RE:Can I make a SP prediction?
Come on psf, they're short since 3+ and milked it with a false insider sell report and the green sushis report... Seriously if they have inside connection, at their place I would let the anticipation rally for pre approval run it course pump the shi-t of it and then short it few days pending the known failure.
They started shorting it, the BLA was not even submited, so no inside knowledge was possible!!!!!!!!!!! I think a lot of newbies did a ten bagger on this one, but having a large base of newbies and inexperienced shareholders prone to emotions makes the shaking easy. It went from what .3 to 3+ in what? 6-8 months, in retrospect it was not surprising to see that run down happen.
I think all this will change on the 14th. To evaluate our odds: FDA stats calls for 85% success on approval for drugs at BLA stage. Efficiency and safety issues account for close to 40% (if I recall eric40's very informative post ) of BLA rejection, which I doubt will be our case since pg is a human protein derivated from human plasma with oustanding/perfect clinicals.
This taken into account: our odds are in the 100%-(100%-40%)*(100%-85%)=91% + out of safety and efficacy, if recall, labelling, cmc could be reason for rejection, see eric's post to calculate the odd for yourself. I even think my calculation is conservative, since the plant was already approved in the past under other Pharma op, maybe the probability % of cmc issues could be tuned down a bit, same for labelling issues probabilities: I think the protocol of treatment is not very complicated and labelling risk could be discounted... But yeah I am managing my stuff with a 90% chance of Ryplazim approval.
Read more at https://www.stockhouse.com/companies/bullboard/t.pli/prometic-life-sciences-inc?postid=27615162#IyMkrpzF1CEqjTyS.99