Here's The Bottom Line For Ocular Therapeutix, Inc. (NASDAQ:OCUL) Shareholders

If you caught our early week coverage you'll know we took a look at Ocular Therapeutix, Inc. (NASDAQ:OCUL) in response to the Adam Feuerstein piece that hit press on Monday. At the time, the company took a hit to its market capitalization on the latter's re-highlighting of a page from the Form 483 issued on the back of an inspection of Dextenza's manufacturing facility.We suggested that the decline was unwarranted and that nothing had changed (in terms of risk reward) between last week and this. In turn, we suggested that the post-dip pricing represented an opportunity to get an exposure to the same fundamentals at a cheaper price.Every so often we get a stark reminder that this is small cap biotechnology.Action this week in Ocular has been one such reminder.The company put out a release on Tuesday announcing that it had submitted an amendment to the FDA detailing certain measures it intends to put in place to overcome the contamination issues uncovered as part of the early 2017 inspection. The ideaswas that the amendment would qualify as what's called a Major Amendment and would, in turn, automatically bring with it a three-month push back on the July 19 PDUFA. The company would implement the measures outlined, another inspection would confirm resolution and the agency would say yes of no on October 19. Simple.Unfortunately, that's not how things played out.On the same day, the FDA issued a response on the initial application – a Complete Response Letter (CRL). The CRL highlighted the manufacturing issues that arose on the back of the initial inspection (specifically, the contamination issues) and is essentially exactly what Ocular (and its shareholders) was trying to avoid (and pre-empt) with the amendment submission.On the issue. Ocular once again took a dive and will open the session on Wednesday at a 32% discount to its Tuesday close.So, back on July 6, this one was trading for $10.41. By July 10, it was at $6.17. At close of play on July 7, Ocular had recovered to $7.61. At market open on Wednesday, it's at $5.15.Talk about rollercoaster and we've not even reached the original PDUFA date yet.What's the driver behind us taking another look at this one today?Well, we suggested $6 might be a nice cheap entry point. For nearly a full session, this looked like it was a valid thesis. Now, not so much. We could bury our heads in the sand and ignore our error. Instead, however, we're going to try and guide our readers out of this mess.What's important here is recognizing that the share price volatility is just noise. Forger about Feuerstein and the initial decline. All that matters is that the CRL requests Ocular sort out some manufacturing concerns. Normally, a company gets this sort of response and has to go about figuring out how it's going to fix the problem before it resubmits to the agency. In this instance, however, and as rooted in the amendment submission, we know that Ocular already has the fix in hand.Take a look at this statement:

"… the FDA did not have the opportunity to review the Company’s close-out response prior to issuing the CRL. In addition, as noted in the CRL, the FDA indicated that applicable sections of the amendment submitted by Ocular Therapeutix could be incorporated when responding to deficiencies noted in the CRL."

There's a good chance, then, that all the company needs to do is repackage its amendment submission into a CRL response (a small job and one that's not going to require any (substantial) additional resources, capital or otherwise) and then fire it back to the FDA.Efficacy isn’t an issue. Safety isn’t a problem. We’ve got three sets of phase III data that reinforce these two statements. The only thing standing between Dextenza and a regulatory green light is contamination issues; issues that the company purports to have already sorted out.What all this means, then, is that – yet again – we could be looking at an opportunity to pickup cheap shares in advance of a market realignment. Just as we said last time, nothing has really changed other than share price and – on the back of nothing more than unfortunate timing – the likely time to approval.As we noted last time, there still exists risk on an exposure here – the recent volatility in this one reminded us of such. With that said, we think this one remains an attractive allocation and especially so given Ocular's current market capitalization.Check out our previous coverage of this one here.We will be updating our subscribers as soon as we know more. For the latest updates on OCUL, sign up below!Image courtesy of Amy via FlickrDisclosure: We have no position in OCUL and have not been compensated for this article.